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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

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ClinicalTrials.gov Identifier: NCT01086267
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: BMS-908662 Drug: Cetuximab Phase 1 Phase 2

Detailed Description:

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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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.

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

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 Posted: March 15, 2010    Key Record Dates
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