Phase 2 Safety & Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI in KRAS-mutant Metastatic Colorectal Carcinoma


Tracking Information

Start Date  ICMJEJanuary 2009
Estimated Primary Completion DateMay 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)		Progression Free Survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00813605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 22, 2008)
  • Incidence of adverse events, significant laboratory abnormalities, incidence of antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
  • Overall Survival, Objective Response, Duration of Response, Time to Response [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEPhase 2 Safety & Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 vs FOLFIRI in KRAS-mutant Metastatic Colorectal Carcinoma
Official Title  ICMJEA Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
Brief Summary

This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMetastatic Colorectal Cancer
Intervention  ICMJE
  • Other: FOLFIRI

    Day 1 of each Cycle

    Combination Therapy of:

    irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion

  • Biological: AMG 655
    AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
  • Biological: AMG 479
    AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
  • Other: Placebo
    Inactive dummy agent (to maintain blind)
Study Arms / Comparison Groups
  • Arm A: Experimental
    AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
    Interventions:
    • Other: FOLFIRI
    • Biological: AMG 655
    • Other: Placebo
  • Arm C: Active Comparator
    AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
    Interventions:
    • Other: FOLFIRI
    • Other: Placebo
  • Arm B: Experimental
    AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
    Interventions:
    • Other: FOLFIRI
    • Biological: AMG 479
    • Other: Placebo

Recruitment Information

Estimated Enrollment  ICMJE150
Estimated Completion DateMay 2013
Estimated Primary Completion DateMay 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  • Mutant-type KRAS tumor at screening
  • ECOG Performance Status of 0 - 1
  • Adequate hematology, renal, hepatic, and coagulation function

Exclusion Criteria:

  • History or known presence of central nervous system metastases
  • History of other malignancy
  • Prior irinotecan-based chemotherapy for advanced/metastatic disease
  • Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  • Uncontrolled cardiovascular disease
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEUnited States,   France,   Hong Kong,   Hungary,   Italy,   Poland,   Russian Federation,   Singapore,   Spain

Administrative Information

NCT ID  ICMJENCT00813605
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20060579
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen