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Completed

NCT Number: NCT01086267

Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Ottawa, Ontario, Canada

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About this study

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
  • Histologic or cytologic confirmation of the diagnosis.
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Adequate organ & marrow function.

Exclusion criteria

  • Uncontrolled or significant cardiovascular disease.
  • Phase 2: Prior therapy with a RAF inhibitor.

Treatment and study plan

BMS-908662

Drug

Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously

Cetuximab

Drug

Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously

Primary outcomes

  1. Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3

    Time frame: Assessments every 1-2 weeks while receiving study drug

Secondary outcomes

  1. Efficacy as determined by estimates of objective response rates and response duration

    Time frame: Efficacy measured at least every 8 weeks while receiving study drug

  2. Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity

    Time frame: PD assessed during the first 4 weeks on study

  3. Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].

    Time frame: PK measured during first 4 weeks on study

  4. Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].

    Time frame: PK measured during first 4 weeks on study

  5. Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].

    Time frame: PK measured during first 4 weeks on study

  6. Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].

    Time frame: PK measured during first 4 weeks on study

  7. Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].

    Time frame: PK measured during first 4 weeks on study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2010
Registry last updated
Jun 27, 2016

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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