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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer, Colon Cancer, Colorectal Cancer, Rectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, 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:

United States: Food and Drug Administration

Study ID:

20060464

NCT ID:

NCT00625651

Start Date:

October 2007

Completion Date:

August 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • AMG 655
  • Bevacizumab
  • Modified FOLFOX6
  • mFOLFOX6
  • FOLFOX
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteLewes, Delaware  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington