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

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer; Colon Cancer; Colorectal Cancer; Rectal Cancer
• Interventions: Drug: AMG 655; Drug: Placebo; Drug: Modified FOLFOX6; Drug: Bevacizumab

• Registration Number: NCT00625651
• Lead Sponsor: Amgen

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 available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-28
• Primary Completion: 2010-08
• Study Completion: 2011-09
• Disposition First Submitted: 2014-01-15
• Disposition First Submitted QC: 2014-01-15
• Disposition First Posted: 2014-02-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 655 Low Dose	AMG 655	AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
AMG 655 Low Dose	Modified FOLFOX6	AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
Placebo	Placebo	Placebo + mFOLFOX6 + Bevacizumab
Placebo	Modified FOLFOX6	Placebo + mFOLFOX6 + Bevacizumab
AMG 655 High Dose	AMG 655	AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
AMG 655 High Dose	Modified FOLFOX6	AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
Placebo	Bevacizumab	Placebo + mFOLFOX6 + Bevacizumab
AMG 655 Low Dose	Bevacizumab	AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
AMG 655 High Dose	Bevacizumab	AMG 655 (high dose) + mFOLFOX6 + Bevacizumab

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Length of study

Secondary Outcome Measures

Name	Time	Method
Time-to-response	Length of study
Objective response rate	Length of study
Duration of response	Length of study
Overall survival	Length of study
AMG 655 pharmacokinetic parameters	Length of study
The incidence of anti-AMG 655 antibody formation	Length of study

Trial Locations

Locations (1)

Research Site; 🇺🇸 Vancouver, Washington, United States