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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00625651
Other study ID # 20060464
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 14, 2008
Last updated March 28, 2014
Start date October 2007
Est. completion date September 2011

Study information

Verified date March 2014
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

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


Intervention

Drug:
Placebo
Inactive dummy AMG 655 (to maintain blind)
AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Modified FOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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
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