Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC) (MAVERICC)
2016年6月30日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
376
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Cork、アイルランド
-
Dublin、アイルランド、24
-
Galway、アイルランド
-
-
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205-7199
-
-
California
-
Bellflower、California、アメリカ、90706
-
Duarte、California、アメリカ、91010
-
Fountain Valley、California、アメリカ、92708
-
Fresno、California、アメリカ、93720
-
Hayward、California、アメリカ、94545
-
Los Angeles、California、アメリカ、90033
-
Oakland、California、アメリカ、94611
-
Pleasant Hill、California、アメリカ、94523
-
Roseville、California、アメリカ、95661
-
Sacramento、California、アメリカ、95817
-
Sacramento、California、アメリカ、95825
-
San Francisco、California、アメリカ、94115
-
San Jose、California、アメリカ、95119
-
Santa Clara、California、アメリカ、95051
-
South San Francisco、California、アメリカ、94080
-
Vallejo、California、アメリカ、94589
-
Walnut Creek、California、アメリカ、94596
-
-
Colorado
-
Denver、Colorado、アメリカ、80218
-
-
Connecticut
-
Stamford、Connecticut、アメリカ、06902
-
Trumbull、Connecticut、アメリカ、06611
-
-
Florida
-
Hollywood、Florida、アメリカ、33021
-
Jacksonville、Florida、アメリカ、32256
-
Miami、Florida、アメリカ、33136
-
Port Saint Lucie、Florida、アメリカ、34952
-
-
Idaho
-
Boise、Idaho、アメリカ、83712
-
-
Illinois
-
Joliet、Illinois、アメリカ、60435
-
Maywood、Illinois、アメリカ、60153
-
Peoria、Illinois、アメリカ、61615
-
-
Indiana
-
Goshen、Indiana、アメリカ、46526
-
Indianapolis、Indiana、アメリカ、46237
-
Terre Haute、Indiana、アメリカ、47802
-
-
Kansas
-
Fairway、Kansas、アメリカ、66205
-
-
Kentucky
-
Elizabethtown、Kentucky、アメリカ、42791
-
-
Maine
-
Scarborough、Maine、アメリカ、04074
-
-
Massachusetts
-
Burlington、Massachusetts、アメリカ、01805
-
-
Montana
-
Billings、Montana、アメリカ、59102
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68506
-
-
New Jersey
-
Cherry Hill、New Jersey、アメリカ、08003
-
Manasquan、New Jersey、アメリカ、08736
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87131-5636
-
Albuquerque、New Mexico、アメリカ、87106
-
Albuquerque、New Mexico、アメリカ、87110
-
Farmington、New Mexico、アメリカ、87401
-
Las Cruces、New Mexico、アメリカ、88011
-
Santa Fe、New Mexico、アメリカ、87505
-
-
New York
-
Rochester、New York、アメリカ、14642
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
-
Greensboro、North Carolina、アメリカ、27403
-
High Point、North Carolina、アメリカ、27262
-
Washington、North Carolina、アメリカ、27889
-
Winston-salem、North Carolina、アメリカ、27103
-
-
Ohio
-
Columbus、Ohio、アメリカ、43219
-
Toledo、Ohio、アメリカ、43623
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73142
-
-
Pennsylvania
-
Dunmore、Pennsylvania、アメリカ、18512
-
Media、Pennsylvania、アメリカ、19063
-
Philadelphia、Pennsylvania、アメリカ、19107
-
Pittsburgh、Pennsylvania、アメリカ、15212
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29414
-
-
Texas
-
Corpus Christi、Texas、アメリカ、78404
-
Houston、Texas、アメリカ、77090
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
-
Wauwatosa、Wisconsin、アメリカ、53226
-
-
-
-
-
Tallinn、エストニア、13419
-
Tartu、エストニア、51014
-
-
-
-
Alberta
-
Edmonton、Alberta、カナダ、T6G 1Z2
-
-
-
-
-
Aarau、スイス、5000
-
Basel、スイス、4031
-
Luzern、スイス、6004
-
Zürich、スイス、8063
-
-
-
-
-
Oslo、ノルウェー、0407
-
-
-
-
-
Coimbra、ポルトガル、3000-075
-
Lisboa、ポルトガル、1649-035
-
Porto、ポルトガル、4200-072
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
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.
|
|
実験的：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.
|
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.
他の名前：
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
時間枠：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 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.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
時間枠：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)
|
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
時間枠：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)
|
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
時間枠：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)
|
|
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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
時間枠：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)
|
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels
時間枠：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)
|
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels
時間枠：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)
|
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels
時間枠：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)
|
|
Overall Survival (OS)
時間枠：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 High ERCC-1 Levels
時間枠：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 Low ERCC-1 Levels
時間枠：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 High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
時間枠：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
時間枠：From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
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)
|
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
時間枠：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
時間枠：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 High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
時間枠：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
時間枠：From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
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.
|
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
時間枠：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 Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
時間枠：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 Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Christiane Langer, M.D.、Genentech, Inc.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年8月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2011年6月14日
QC基準を満たした最初の提出物
2011年6月15日
最初の投稿 (見積もり)
2011年6月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年8月11日
QC基準を満たした最後の更新が送信されました
2016年6月30日
最終確認日
2016年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ML25710
- 2011-004755-39 (EudraCT番号)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。