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

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: BMS-908662; Drug: Cetuximab

• Registration Number: NCT01086267
• Lead Sponsor: 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

Detailed Description

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-15
• Study Start: 2010-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-908662 + Cetuximab (B2)	Cetuximab	Phase 2
Cetuximab (A1)	Cetuximab	Phase 1
BMS-908662 (A1)	BMS-908662	Phase 1
BMS-908662 (B1)	BMS-908662	Phase 2
BMS-908662 + Cetuximab (B2)	BMS-908662	Phase 2

Primary Outcome Measures

Name	Time	Method
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3	Assessments every 1-2 weeks while receiving study drug

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].	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)].	PK measured during first 4 weeks on study
Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity	PD assessed during the first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].	PK measured during first 4 weeks on study
Efficacy as determined by estimates of objective response rates and response duration	Efficacy measured at least every 8 weeks while receiving study drug
Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].	PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].	PK measured during first 4 weeks on study

Trial Locations

Locations (3)

Oncology Research Associates D/B/A; 🇺🇸 Scottsdale, Arizona, United States

Local Institution; 🇨🇦 Ottawa, Ontario, Canada

Usc Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States