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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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-908662
BMS-908662
Cetuximab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Research Associates D/B/A
  • Usc Norris Comprehensive Cancer Center
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BMS-908662 (A1)

Cetuximab (A1)

BMS-908662 (B1)

BMS-908662 + Cetuximab (B2)

Arm Description

Phase 1

Phase 1

Phase 2

Phase 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy as determined by estimates of objective response rates and response duration
Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity
Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].
Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].
Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].
Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].
Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].

Full Information

First Posted
March 11, 2010
Last Updated
June 23, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01086267
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-908662 (A1)
Arm Type
Experimental
Arm Description
Phase 1
Arm Title
Cetuximab (A1)
Arm Type
Experimental
Arm Description
Phase 1
Arm Title
BMS-908662 (B1)
Arm Type
Experimental
Arm Description
Phase 2
Arm Title
BMS-908662 + Cetuximab (B2)
Arm Type
Experimental
Arm Description
Phase 2
Intervention Type
Drug
Intervention Name(s)
BMS-908662
Intervention Description
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
Intervention Type
Drug
Intervention Name(s)
BMS-908662
Intervention Description
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity
Time Frame
PD assessed during the first 4 weeks on study
Title
Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].
Time Frame
PK measured during first 4 weeks on study
Title
Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].
Time Frame
PK measured during first 4 weeks on study
Title
Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].
Time Frame
PK measured during first 4 weeks on study
Title
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
Title
Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].
Time Frame
PK measured during first 4 weeks on study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Research Associates D/B/A
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Usc Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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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