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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

Length of Study

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20060579

NCT ID:

NCT00813605

Start Date:

March 2009

Completion Date:

June 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • AMG 655
  • AMG 479
  • Colon Cancer
  • Rectal Cancer
  • Monoclonal Antibody
  • Clinical Trial
  • Colorectal Cancer
  • metastatic colorectal cancer
  • metastatic cancer
  • antibody-2nd line
  • KRAS
  • adenocarcinoma
  • Carcinoma
  • Colorectal Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Hays, Kansas  
Research Site Ashland, Kentucky  
Research Site Beverly, Massachusetts  
Research Site Hooksett, New Hampshire  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Abilene, Texas  
Research Site Abington, Virginia