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Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00625651
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 14, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2008)
Progression-free survival [ Time Frame: Length of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
  • Phase 1b:To determine the maximum tolerated dose of AMG 655 that can be administered in combination with mFOLFOX6/bevacizumab [ Time Frame: From informed consent to the Safety Follow-Up Visit ]
  • Phase 2: To estimate the efficacy of AMG 655 in combination with mFOLFOX6/bevacizumab [ Time Frame: From screening to disease progression ]
Change History Complete list of historical versions of study NCT00625651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
  • Objective response rate [ Time Frame: Length of study ]
  • Duration of response [ Time Frame: Length of study ]
  • Time-to-response [ Time Frame: Length of study ]
  • Overall survival [ Time Frame: Length of study ]
  • AMG 655 pharmacokinetic parameters [ Time Frame: Length of study ]
  • The incidence of anti-AMG 655 antibody formation [ Time Frame: Length of study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Official Title  ICMJE A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
Brief Summary

This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).

The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
Intervention  ICMJE
  • Drug: Placebo
    Inactive dummy AMG 655 (to maintain blind)
  • Drug: AMG 655
    AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
  • Drug: Modified FOLFOX6
    Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
    Other Name: mFOLFOX6
  • Drug: Bevacizumab
    Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Study Arms  ICMJE
  • Experimental: AMG 655 Low Dose
    AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
    Interventions:
    • Drug: AMG 655
    • Drug: Modified FOLFOX6
    • Drug: Bevacizumab
  • Placebo Comparator: Placebo
    Placebo + mFOLFOX6 + Bevacizumab
    Interventions:
    • Drug: Placebo
    • Drug: Modified FOLFOX6
    • Drug: Bevacizumab
  • Experimental: AMG 655 High Dose
    AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
    Interventions:
    • Drug: AMG 655
    • Drug: Modified FOLFOX6
    • Drug: Bevacizumab
Publications * Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2009)
202
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2008)
192
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
  • Subjects with measurable or unmeasurable disease
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Men or women at least 18 years of age
  • Adequate hematologic, renal, hepatic and coagulation function

Exclusion Criteria:

  • History or known presence of central nervous system (CNS) metastases
  • Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
  • Any investigational agent or therapy for advanced or metastatic CRC
  • Clinically significant cardiac disease
  • Clinically significant peripheral neuropathy
  • Active inflammatory bowel disease
  • Recent gastrointestinal ulcer or hemorrhage
  • Recent arterial thrombotic event or pulmonary embolus
  • Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
  • Recent major surgical procedure or not yet recovered from major surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625651
Other Study ID Numbers  ICMJE 20060464
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP