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- Register voor klinische proeven in de VS.
- Klinische proef NCT01374425
Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC) (MAVERICC)
30 juni 2016 bijgewerkt door: Genentech, Inc.
MAVERICC (Marker Evaluation for Avastin Research in CRC): A Randomized Phase II Study of Bevacizumab+mFOLFOX6 Vs. Bevacizumab+FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI).
The study population will consist of participants with first-line mCRC.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
376
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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Tallinn, Estland, 13419
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Tartu, Estland, 51014
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Cork, Ierland
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Dublin, Ierland, 24
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Galway, Ierland
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Oslo, Noorwegen, 0407
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Coimbra, Portugal, 3000-075
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Lisboa, Portugal, 1649-035
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Porto, Portugal, 4200-072
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205-7199
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California
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Bellflower, California, Verenigde Staten, 90706
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Duarte, California, Verenigde Staten, 91010
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Fountain Valley, California, Verenigde Staten, 92708
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Fresno, California, Verenigde Staten, 93720
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Hayward, California, Verenigde Staten, 94545
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Los Angeles, California, Verenigde Staten, 90033
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Oakland, California, Verenigde Staten, 94611
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Pleasant Hill, California, Verenigde Staten, 94523
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Roseville, California, Verenigde Staten, 95661
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Sacramento, California, Verenigde Staten, 95817
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Sacramento, California, Verenigde Staten, 95825
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San Francisco, California, Verenigde Staten, 94115
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San Jose, California, Verenigde Staten, 95119
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Santa Clara, California, Verenigde Staten, 95051
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South San Francisco, California, Verenigde Staten, 94080
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Vallejo, California, Verenigde Staten, 94589
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Walnut Creek, California, Verenigde Staten, 94596
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Colorado
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Denver, Colorado, Verenigde Staten, 80218
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Connecticut
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Stamford, Connecticut, Verenigde Staten, 06902
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Trumbull, Connecticut, Verenigde Staten, 06611
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Florida
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Hollywood, Florida, Verenigde Staten, 33021
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Jacksonville, Florida, Verenigde Staten, 32256
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Miami, Florida, Verenigde Staten, 33136
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Port Saint Lucie, Florida, Verenigde Staten, 34952
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Idaho
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Boise, Idaho, Verenigde Staten, 83712
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Illinois
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Joliet, Illinois, Verenigde Staten, 60435
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Maywood, Illinois, Verenigde Staten, 60153
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Peoria, Illinois, Verenigde Staten, 61615
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Indiana
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Goshen, Indiana, Verenigde Staten, 46526
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Indianapolis, Indiana, Verenigde Staten, 46237
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Terre Haute, Indiana, Verenigde Staten, 47802
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Kansas
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Fairway, Kansas, Verenigde Staten, 66205
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Kentucky
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Elizabethtown, Kentucky, Verenigde Staten, 42791
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Maine
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Scarborough, Maine, Verenigde Staten, 04074
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Massachusetts
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Burlington, Massachusetts, Verenigde Staten, 01805
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Montana
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Billings, Montana, Verenigde Staten, 59102
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68506
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New Jersey
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Cherry Hill, New Jersey, Verenigde Staten, 08003
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Manasquan, New Jersey, Verenigde Staten, 08736
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87131-5636
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Albuquerque, New Mexico, Verenigde Staten, 87106
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Albuquerque, New Mexico, Verenigde Staten, 87110
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Farmington, New Mexico, Verenigde Staten, 87401
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Las Cruces, New Mexico, Verenigde Staten, 88011
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Santa Fe, New Mexico, Verenigde Staten, 87505
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New York
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Rochester, New York, Verenigde Staten, 14642
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
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Greensboro, North Carolina, Verenigde Staten, 27403
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High Point, North Carolina, Verenigde Staten, 27262
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Washington, North Carolina, Verenigde Staten, 27889
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Winston-salem, North Carolina, Verenigde Staten, 27103
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Ohio
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Columbus, Ohio, Verenigde Staten, 43219
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Toledo, Ohio, Verenigde Staten, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73142
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Pennsylvania
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Dunmore, Pennsylvania, Verenigde Staten, 18512
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Media, Pennsylvania, Verenigde Staten, 19063
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
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Pittsburgh, Pennsylvania, Verenigde Staten, 15212
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29414
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Texas
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Corpus Christi, Texas, Verenigde Staten, 78404
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Houston, Texas, Verenigde Staten, 77090
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
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Wauwatosa, Wisconsin, Verenigde Staten, 53226
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Aarau, Zwitserland, 5000
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Basel, Zwitserland, 4031
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Luzern, Zwitserland, 6004
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Zürich, Zwitserland, 8063
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST Version 1.1
- Archival tumor tissue sample must be requested and available prior to study entry. If no archival tumor tissue sample is available, a fresh biopsy tissue sample must be obtained but should be discussed first with the medical monitor. A copy of the local pathology report must be submitted along with the specimens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with treated brain metastases are eligible for study participation. Participants may not receive ongoing treatment with steroids at Screening. Anticonvulsants (at stable dose) are allowed. Treatment for brain metastases may be whole-brain radiotherapy, radiosurgery, neurosurgery, or a combination as deemed appropriate by the treating physician. Radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization.
- Female participants should not be pregnant or breastfeeding. Female participants with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. Female participants with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.
- Male participants must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized.
Exclusion Criteria:
- Any prior systemic treatment for mCRC
- Adjuvant chemotherapy for CRC completed <12 months
- Evidence of Gilbert's syndrome or of homozygosity for the UGT1A1*28 allele
- Known positivity for human immunodeficiency virus (HIV)
- Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
- Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
- Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
- Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Bevacizumab + mFOLFOX6
Participants will receive bevacizumab plus mFOLFOX6 by intravenous (IV) infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity.
Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin, with bevacizumab continued in 3-week cycles.
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5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity.
If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Andere namen:
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Oxaliplatin 85 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
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Experimenteel: Bevacizumab + FOLFIRI
Participants will receive bevacizumab plus FOLFIRI by IV infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity.
Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan, with bevacizumab continued in 3-week cycles.
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5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity.
If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Andere namen:
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
Irinotecan 180 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm).
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Overall Survival (OS)
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
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Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death (maximum up to 45 months overall)
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OS in Participants With High ERCC-1 Levels
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
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Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death (maximum up to 45 months overall)
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OS in Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
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Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From Baseline until death (maximum up to 45 months overall)
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OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
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Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
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Percentage of Participants With Objective Response According to RECIST Version 1.1
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
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From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Percentage of Participants With Disease Control According to RECIST Version 1.1
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
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From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
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From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
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Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS
Tijdsspanne: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Tijdsspanne: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Tijdsspanne: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Christiane Langer, M.D., Genentech, Inc.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2011
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 juli 2015
Studieregistratiedata
Eerst ingediend
14 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
15 juni 2011
Eerst geplaatst (Schatting)
16 juni 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
11 augustus 2016
Laatste update ingediend die voldeed aan QC-criteria
30 juni 2016
Laatst geverifieerd
1 juni 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Colorectale neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Beschermende middelen
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Micronutriënten
- Vitaminen
- Topoisomerase I-remmers
- Tegengif
- Vitamine B-complex
- Fluoruracil
- Capecitabine
- Oxaliplatine
- Bevacizumab
- Leucovorin
- Irinotecan
Andere studie-ID-nummers
- ML25710
- 2011-004755-39 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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