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

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Drug: Bevacizumab; Drug: Placebo; Drug: Modified FOLFOX6; Drug: AMG 655

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625651

20060464

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 3 patient groups, including a placebo group

AMG 655 Low Dose

Experimental group

Description:

AMG 655 (low dose) + mFOLFOX6 + Bevacizumab

Treatment:

Drug: Modified FOLFOX6

Drug: Bevacizumab

Drug: AMG 655

Placebo

Placebo Comparator group

Description:

Placebo + mFOLFOX6 + Bevacizumab

Treatment:

Drug: Modified FOLFOX6

Drug: Bevacizumab

Drug: Placebo

AMG 655 High Dose

Experimental group

Description:

AMG 655 (high dose) + mFOLFOX6 + Bevacizumab

Treatment:

Drug: Modified FOLFOX6

Drug: Bevacizumab

Drug: AMG 655