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BMS-908662

Phase 1

Colorectal Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 27, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

BMS-908662 · 2 trials · 2 indications

Phase 1 2
NCT01245556Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced MelanomaMelanoma
COMPLETED8 Analytics
NCT01086267Safety 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 CancerColorectal Cancer
COMPLETED17 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
MelanomaUnlock trial analytics
PHASE1COMPLETED
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
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Assessments approximately every 3 weeks throughout the duration of the trial
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 Endpoints

Efficacy as determined by estimates of objective response rates and response duration
Efficacy measured every 6 weeks until week 48, then every 12 weeks
PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index
PK measured during first 4 weeks on study
PD will be assessed by evaluating markers of RAS/RAF pathway activity
PD assessed during the first 4 weeks on study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-908662 or Ipilimumab (A)EXPERIMENTAL -
BMS-908662 or Ipilimumab (B)EXPERIMENTAL -
BMS-908662 (A1)EXPERIMENTALPhase 1
Cetuximab (A1)EXPERIMENTALPhase 1
BMS-908662 (B1)EXPERIMENTALPhase 2
BMS-908662 + Cetuximab (B2)EXPERIMENTALPhase 2

Interventions

NameTypeDescription
BMS-908662DRUGCapsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
IpilimumabDRUGVial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
CetuximabDRUGVial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion: * Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma * Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation * ECOG ≤ 1 * Adequate organ \& ...

Countries:United StatesCanada
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Frequently asked questions about BMS-908662

What is BMS-908662 used for?

BMS-908662 is an investigational small molecule being studied for the treatment of colorectal cancer and melanoma. It was evaluated in Phase 1 clinical trials for these oncology indications.

Who makes BMS-908662?

BMS-908662 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY.

What phase is BMS-908662 in?

BMS-908662 is in Phase 1 clinical development. It has completed Phase 1 trials, and it is not approved by the FDA.

What clinical trials is BMS-908662 in?

BMS-908662 has been studied in two completed Phase 1 trials: NCT01086267, which tested it alone or with cetuximab in advanced or metastatic colorectal cancer, and NCT01245556, which tested it with ipilimumab in advanced melanoma.

Is BMS-908662 the same as any other drug?

No alternative names for BMS-908662 have been disclosed. It is identified by its investigational code name.