Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00625651

Purpose

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.

Condition	Intervention	Phase
Metastatic Colorectal Cancer Colon Cancer Colorectal Cancer Rectal Cancer	Drug: Placebo Drug: AMG 655	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Time-to-response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
The incidence of anti-AMG 655 antibody formation [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
AMG 655 pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]

Enrollment:	202
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AMG 655 Low Dose: Experimental AMG 655 (low dose) + mFOLFOX6 + Bevacizumab	Drug: AMG 655 AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Placebo: Placebo Comparator Placebo + mFOLFOX6 + Bevacizumab	Drug: Placebo Inactive dummy AMG 655 (to maintain blind)
AMG 655 High Dose: Experimental AMG 655 (high dose) + mFOLFOX6 + Bevacizumab	Drug: AMG 655 AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625651

Show 54 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060464
Study First Received:	February 14, 2008
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00625651 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Colon Cancer
Colorectal Cancer
AMG 655
Bevacizumab

Modified FOLFOX6
mFOLFOX6
FOLFOX
Rectal Cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Benzocaine
Rectal Neoplasm
Bevacizumab
Intestinal Diseases
Angiogenesis Inhibitors

Rectal Diseases
Intestinal Neoplasms
Antibodies
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Digestive System Neoplasms
Antineoplastic Agents
Rectal Neoplasms
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Bevacizumab
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009