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NCT Number: NCT00625651

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Hot Springs, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Inactive dummy AMG 655 (to maintain blind)

AMG 655

Drug

AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

Modified FOLFOX6

Drug

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)

Other names: mFOLFOX6

Bevacizumab

Drug

Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Primary outcomes

  1. Progression-free survival

    Time frame: Length of study

Secondary outcomes

  1. Objective response rate

    Time frame: Length of study

  2. Duration of response

    Time frame: Length of study

  3. Time-to-response

    Time frame: Length of study

  4. Overall survival

    Time frame: Length of study

  5. AMG 655 pharmacokinetic parameters

    Time frame: Length of study

  6. The incidence of anti-AMG 655 antibody formation

    Time frame: Length of study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Feb 28, 2008
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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