Colorectal Cancer Clinical Trial
Official title:
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
| Verified date | March 2014 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed
to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab
compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated
metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be
measured by progression-free survival, objective response rate, time to response, duration
of response, and overall survival. This study is also designed to evaluate the safety and
tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate
anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
| Status | Completed |
| Enrollment | 202 |
| Est. completion date | September 2011 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Burlington | North Carolina |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Downey | California |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Gastonia | North Carolina |
| United States | Research Site | Great Falls | Montana |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Harrisburg | Pennsylvania |
| United States | Research Site | Harvey | Illinois |
| United States | Research Site | Hot Springs | Arkansas |
| United States | Research Site | Hudson | New York |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Kissimmee | Florida |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lawrenceville | Georgia |
| United States | Research Site | Leesburg | Florida |
| United States | Research Site | Loma Linda | California |
| United States | Research Site | Long Branch | New Jersey |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Maywood | Illinois |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Middletown | Ohio |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New York | New York |
| United States | Research Site | Newark | Delaware |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Orange | California |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Pottsville | Pennsylvania |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Richardson | Texas |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | San Diego | California |
| United States | Research Site | St. Joseph | Michigan |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Vancouver | Washington |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wichita Falls | Texas |
| United States | Research Site | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States,
Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival | Length of study | No | |
| Secondary | Objective response rate | Length of study | No | |
| Secondary | Duration of response | Length of study | No | |
| Secondary | Time-to-response | Length of study | No | |
| Secondary | Overall survival | Length of study | Yes | |
| Secondary | AMG 655 pharmacokinetic parameters | Length of study | Yes | |
| Secondary | The incidence of anti-AMG 655 antibody formation | Length of study | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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