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Clinical Trials/NCT00813605
NCT00813605
Completed
Phase 2

A 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

NantCell, Inc.1 site in 1 country155 target enrollmentMarch 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Metastatic Colorectal Cancer
Sponsor
NantCell, Inc.
Enrollment
155
Locations
1
Primary Endpoint
Progression Free Survival
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
June 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  • Mutant-type KRAS tumor at screening
  • Eastern Cooperative Oncology Group (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

Outcomes

Primary Outcomes

Progression Free Survival

Time Frame: Length of Study

Secondary Outcomes

  • Significant laboratory abnormalities(Length of Study)
  • Incidence of antibody formation(Length of Study)
  • Overall Survival, Objective Response, Duration of Response, Time to Response(Length of Study)
  • Incidence of adverse events(Length of Study)

Study Sites (1)

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