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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01086267
First Posted: March 15, 2010
Last Update Posted: June 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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

Condition Intervention Phase
Colorectal Cancer Drug: BMS-908662 Drug: Cetuximab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity [ Time Frame: PD assessed during the first 4 weeks on study ]
  • Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin]. [ Time Frame: PK measured during first 4 weeks on study ]
  • Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax]. [ Time Frame: PK measured during first 4 weeks on study ]
  • Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax]. [ Time Frame: PK measured during first 4 weeks on study ]
  • 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 ]
  • Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI]. [ Time Frame: PK measured during first 4 weeks on study ]

Enrollment: 17
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-908662 (A1)
Phase 1
Drug: BMS-908662
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
Experimental: Cetuximab (A1)
Phase 1
Drug: Cetuximab
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Experimental: BMS-908662 (B1)
Phase 2
Drug: BMS-908662
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Experimental: BMS-908662 + Cetuximab (B2)
Phase 2
Drug: BMS-908662
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Drug: Cetuximab
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously

Detailed Description:

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086267


Locations
United States, Arizona
Oncology Research Associates D/B/A
Scottsdale, Arizona, United States, 85258
United States, California
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 1C3
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01086267     History of Changes
Other Study ID Numbers: CA206-001
2010-018944-15 ( EudraCT Number )
First Submitted: March 11, 2010
First Posted: March 15, 2010
Last Update Posted: June 27, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents