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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00625651

First received: February 14, 2008

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

May 17, 2012

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Phase 2: To estimate the efficacy of AMG 655 in combination with mFOLFOX6/bevacizumab [ Time Frame: From screening to disease progression ] [ Designated as safety issue: No ]
Phase 1b:To determine the maximum tolerated dose of AMG 655 that can be administered in combination with mFOLFOX6/bevacizumab [ Time Frame: From informed consent to the Safety Follow-Up Visit ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00625651 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
AMG 655 pharmacokinetic parameters [ 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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Colorectal Cancer
Colon Cancer
Colorectal Cancer
Rectal Cancer

Intervention ^ICMJE

Drug: Placebo
Inactive dummy AMG 655 (to maintain blind)
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

Study Arm (s)

Experimental: AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab

Intervention: Drug: AMG 655
Placebo Comparator: Placebo
Placebo + mFOLFOX6 + Bevacizumab

Intervention: Drug: Placebo
Experimental: AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab

Intervention: Drug: AMG 655

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

202

Estimated Completion Date

August 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00625651

Other Study ID Numbers ^ICMJE

20060464

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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