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
Phase 1: Single Arm Study Phase 2: Randomized Controlled, Parallel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Oncology Research Associates D/B/A
Scottsdale, Arizona, United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution
Ottawa, Ontario, Canada
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
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
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