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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 Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Lewes, Delaware  
Research Site Washington, District of Columbia  
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 Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington