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Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC) (MAVERICC)

30. Juni 2016 aktualisiert von: 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.

Studienübersicht

Status

Status

Zeigt den aktuellen Rekrutierungsstatus oder den erweiterten Zugriffsstatus an.
Abgeschlossen

Bedingungen

Bedingungen

Die Krankheit, Störung, das Syndrom, die Krankheit oder die Verletzung, die untersucht wird. Auf ClinicalTrials.gov können die Bedingungen auch andere gesundheitsbezogene Themen wie Lebensdauer, Lebensqualität und Gesundheitsrisiken umfassen.

Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.

Studientyp

Studientyp

Beschreibt die Art einer klinischen Studie. Zu den Studientypen gehören Interventionsstudien (auch klinische Studien genannt), Beobachtungsstudien (einschließlich Patientenregister) und erweiterter Zugang.
Interventionell

Einschreibung (Tatsächlich)

Einschreibung

Die Anzahl der Teilnehmer an einer klinischen Studie. Die „erwartete“ Einschreibung ist die Zielzahl an Teilnehmern, die die Forscher für die Studie benötigen.
376

Phase

Phase

Das Stadium einer klinischen Studie, in der ein Medikament oder ein biologisches Produkt untersucht wird, basierend auf Definitionen, die von der U.S. Food and Drug Administration (FDA) entwickelt wurden. Die Phase richtet sich nach dem Ziel der Studie, der Anzahl der Teilnehmer und anderen Merkmalen. Es gibt fünf Phasen: Frühe Phase 1 (früher als Phase 0 aufgeführt), Phase 1, Phase 2, Phase 3 und Phase 4. Nicht zutreffend wird verwendet, um Studien ohne von der FDA definierte Phasen zu beschreiben, einschließlich Studien zu Geräten oder Verhaltensinterventionen.
  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Estland
      • Tallinn, Estland, 13419
      • Tartu, Estland, 51014
  • Irland
      • Cork, Irland
      • Dublin, Irland, 24
      • Galway, Irland
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
  • Norwegen
      • Oslo, Norwegen, 0407
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1649-035
      • Porto, Portugal, 4200-072
  • Schweiz
      • Aarau, Schweiz, 5000
      • Basel, Schweiz, 4031
      • Luzern, Schweiz, 6004
      • Zürich, Schweiz, 8063
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72205-7199
    • California
      • Bellflower, California, Vereinigte Staaten, 90706
      • Duarte, California, Vereinigte Staaten, 91010
      • Fountain Valley, California, Vereinigte Staaten, 92708
      • Fresno, California, Vereinigte Staaten, 93720
      • Hayward, California, Vereinigte Staaten, 94545
      • Los Angeles, California, Vereinigte Staaten, 90033
      • Oakland, California, Vereinigte Staaten, 94611
      • Pleasant Hill, California, Vereinigte Staaten, 94523
      • Roseville, California, Vereinigte Staaten, 95661
      • Sacramento, California, Vereinigte Staaten, 95817
      • Sacramento, California, Vereinigte Staaten, 95825
      • San Francisco, California, Vereinigte Staaten, 94115
      • San Jose, California, Vereinigte Staaten, 95119
      • Santa Clara, California, Vereinigte Staaten, 95051
      • South San Francisco, California, Vereinigte Staaten, 94080
      • Vallejo, California, Vereinigte Staaten, 94589
      • Walnut Creek, California, Vereinigte Staaten, 94596
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80218
    • Connecticut
      • Stamford, Connecticut, Vereinigte Staaten, 06902
      • Trumbull, Connecticut, Vereinigte Staaten, 06611
    • Florida
      • Hollywood, Florida, Vereinigte Staaten, 33021
      • Jacksonville, Florida, Vereinigte Staaten, 32256
      • Miami, Florida, Vereinigte Staaten, 33136
      • Port Saint Lucie, Florida, Vereinigte Staaten, 34952
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83712
    • Illinois
      • Joliet, Illinois, Vereinigte Staaten, 60435
      • Maywood, Illinois, Vereinigte Staaten, 60153
      • Peoria, Illinois, Vereinigte Staaten, 61615
    • Indiana
      • Goshen, Indiana, Vereinigte Staaten, 46526
      • Indianapolis, Indiana, Vereinigte Staaten, 46237
      • Terre Haute, Indiana, Vereinigte Staaten, 47802
    • Kansas
      • Fairway, Kansas, Vereinigte Staaten, 66205
    • Kentucky
      • Elizabethtown, Kentucky, Vereinigte Staaten, 42791
    • Maine
      • Scarborough, Maine, Vereinigte Staaten, 04074
    • Massachusetts
      • Burlington, Massachusetts, Vereinigte Staaten, 01805
    • Montana
      • Billings, Montana, Vereinigte Staaten, 59102
    • Nebraska
      • Lincoln, Nebraska, Vereinigte Staaten, 68506
    • New Jersey
      • Cherry Hill, New Jersey, Vereinigte Staaten, 08003
      • Manasquan, New Jersey, Vereinigte Staaten, 08736
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87131-5636
      • Albuquerque, New Mexico, Vereinigte Staaten, 87106
      • Albuquerque, New Mexico, Vereinigte Staaten, 87110
      • Farmington, New Mexico, Vereinigte Staaten, 87401
      • Las Cruces, New Mexico, Vereinigte Staaten, 88011
      • Santa Fe, New Mexico, Vereinigte Staaten, 87505
    • New York
      • Rochester, New York, Vereinigte Staaten, 14642
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
      • Greensboro, North Carolina, Vereinigte Staaten, 27403
      • High Point, North Carolina, Vereinigte Staaten, 27262
      • Washington, North Carolina, Vereinigte Staaten, 27889
      • Winston-salem, North Carolina, Vereinigte Staaten, 27103
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43219
      • Toledo, Ohio, Vereinigte Staaten, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73142
    • Pennsylvania
      • Dunmore, Pennsylvania, Vereinigte Staaten, 18512
      • Media, Pennsylvania, Vereinigte Staaten, 19063
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29414
    • Texas
      • Corpus Christi, Texas, Vereinigte Staaten, 78404
      • Houston, Texas, Vereinigte Staaten, 77090
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
      • Wauwatosa, Wisconsin, Vereinigte Staaten, 53226

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Zulassungskriterien

Die wichtigsten Voraussetzungen, die Personen erfüllen müssen, die an einer klinischen Studie teilnehmen möchten, bzw. welche Eigenschaften sie mitbringen müssen. Auswahlkriterien bestehen sowohl aus Einschlusskriterien (die erforderlich sind, damit eine Person an der Studie teilnehmen kann) als auch aus Ausschlusskriterien (die eine Person an der Teilnahme hindern). Arten von Zulassungskriterien umfassen, ob eine Studie gesunde Freiwillige akzeptiert, Alters- oder Altersgruppenanforderungen hat oder durch das Geschlecht begrenzt ist.

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm

Teilnehmergruppe / Arm

Eine Gruppe oder Untergruppe von Teilnehmern an einer klinischen Studie, die gemäß dem Protokoll der Studie eine bestimmte Intervention/Behandlung oder keine Intervention erhält.
Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.
Experimental: 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.
Arzneimittel: 5-Fluorouracil
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.
Arzneimittel: Bevacizumab
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:
  • Avastin
Arzneimittel: Leucovorin
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.
Arzneimittel: Oxaliplatin
Oxaliplatin 85 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Arzneimittel: Capecitabine
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.
Experimental: 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.
Arzneimittel: 5-Fluorouracil
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.
Arzneimittel: Bevacizumab
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:
  • Avastin
Arzneimittel: Leucovorin
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.
Arzneimittel: Capecitabine
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.
Arzneimittel: Irinotecan
Irinotecan 180 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

Was misst die Studie?

Primäre Ergebnismessungen

Primäre Ergebnismessungen

Im Protokoll einer klinischen Studie die geplante Ergebnismessung, die für die Bewertung der Wirkung einer Intervention/Behandlung am wichtigsten ist. Die meisten klinischen Studien haben einen primären Endpunkt, aber einige haben mehr als einen.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Sekundäre Ergebnismessungen

Im Protokoll einer klinischen Studie ein geplantes Ergebnismaß, das nicht so wichtig ist wie das primäre Ergebnismaß für die Bewertung der Wirkung einer Intervention, aber dennoch von Interesse ist. Die meisten klinischen Studien haben mehr als einen sekundären Endpunkt.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sponsor

Die Organisation oder Person, die die Studie initiiert und die Autorität und Kontrolle über die Studie hat.
Genentech, Inc.

Ermittler

Ermittler

Ein Forscher, der an einer klinischen Studie beteiligt ist. Zu den verwandten Begriffen gehören Studienleiter, Unterprüfer am Standort, Studienleiter, Studienleiter und Studienleiter.
  • Studienleiter: Christiane Langer, M.D., Genentech, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

Studienbeginn

Das tatsächliche Datum, an dem der erste Teilnehmer in eine klinische Studie aufgenommen wurde. Das „voraussichtliche“ Studienstartdatum ist das Datum, von dem die Forscher glauben, dass es das Studienstartdatum sein wird.
1. August 2011

Primärer Abschluss (Tatsächlich)

Primärer Abschluss

Das Datum, an dem der letzte Teilnehmer einer klinischen Studie untersucht wurde oder eine Intervention erhalten hat, um endgültige Daten für das primäre Ergebnis zu sammeln. Ob die klinische Studie protokollgemäß endete oder beendet wurde, hat keinen Einfluss auf dieses Datum. Bei klinischen Studien mit mehr als einem primären Ergebnismaß mit unterschiedlichen Abschlussdaten bezieht sich dieser Begriff auf das Datum, an dem die Datenerhebung für alle primären Ergebnismaße abgeschlossen ist. Das „erwartete“ primäre Abschlussdatum ist das Datum, von dem die Forscher glauben, dass es das primäre Abschlussdatum für die Studie sein wird.
1. Mai 2015

Studienabschluss (Tatsächlich)

Studienabschluss

Das Datum, an dem der letzte Teilnehmer an einer klinischen Studie untersucht wurde oder eine Intervention/Behandlung erhielt, um endgültige Daten für die primären Ergebnismaße, sekundären Ergebnismaße und Nebenwirkungen zu sammeln (d. h. der letzte Besuch des letzten Teilnehmers). Das „voraussichtliche“ Abschlussdatum der Studie ist das Datum, von dem die Forscher glauben, dass es das Abschlussdatum der Studie sein wird.
1. Juli 2015

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht bei ClinicalTrials.gov eingereicht hat. Zwischen dem Datum der ersten Einreichung und der Verfügbarkeit des Datensatzes auf ClinicalTrials.gov (dem ersten veröffentlichten Datum) liegt in der Regel eine Verzögerung von einigen Tagen.
14. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht einreicht, der den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) entspricht. Der Sponsor oder Prüfer muss möglicherweise einen Studienbericht ein- oder mehrmals überarbeiten und einreichen, bevor die QC-Überprüfungskriterien von NLM erfüllt sind. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
15. Juni 2011

Zuerst gepostet (Schätzen)

Zuerst gepostet

Das Datum, an dem der Studienbericht zum ersten Mal auf ClinicalTrials.gov verfügbar war, nachdem die Qualitätskontrolle (QC) der National Library of Medicine (NLM) abgeschlossen wurde. Zwischen dem Datum, an dem der Studiensponsor oder Prüfer den Studienbericht eingereicht hat, und dem ersten veröffentlichten Datum liegt in der Regel eine Verzögerung von einigen Tagen.
16. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

Letztes Update gepostet

Das letzte Datum, an dem Änderungen an einem Studienbericht auf ClinicalTrials.gov verfügbar gemacht wurden. Es kann eine Verzögerung zwischen der Übermittlung der Änderungen an ClinicalTrials.gov durch den Sponsor oder Prüfer der Studie (Datum der letzten eingereichten Aktualisierung) und dem Datum der letzten Veröffentlichung der Aktualisierung geben.
11. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Das letzte Datum, an dem der Studiensponsor oder Prüfer Änderungen an einem Studienbericht eingereicht hat, die mit den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) übereinstimmen. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
30. Juni 2016

Zuletzt verifiziert

Zuletzt verifiziert

Das letzte Datum, an dem der Studiensponsor oder Prüfer die Informationen über eine klinische Studie auf ClinicalTrials.gov als richtig und aktuell bestätigt hat. Wenn eine Studie den Rekrutierungsstatus Recruiting hat; noch keine Rekrutierung; oder aktiv, keine Rekrutierung wurde innerhalb der letzten 2 Jahre nicht bestätigt, der Rekrutierungsstatus der Studie wird als unbekannt angezeigt.
1. Juni 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

Andere Studien-ID-Nummern

Andere Identifikatoren oder ID-Nummern als die NCT-Nummer, die einer klinischen Studie vom Sponsor der Studie, Geldgebern oder anderen zugewiesen werden. Diese Nummern können eindeutige Kennungen von anderen Studienregistern und Zuschussnummern der National Institutes of Health enthalten.
  • ML25710
  • 2011-004755-39 (EudraCT-Nummer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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