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Report for Clinical Trial NCT01086267

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01086267 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

3 Interventions

Name: BMS-908662

Description: Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
Type: Drug
Group Labels: 1

BMS-908662 (A1)

Name: BMS-908662

Description: Capsules, Oral, (TBD) mg, Q 12 h, Continuously
Type: Drug
Group Labels: 2

BMS-908662 (B1) BMS-908662 + Cetuximab (B2)

Name: Cetuximab

Description: Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
Type: Drug
Group Labels: 2

BMS-908662 + Cetuximab (B2) Cetuximab (A1)


Primary Outcomes

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

Time: Assessments every 1-2 weeks while receiving study drug

Secondary Outcomes

Measure: Efficacy as determined by estimates of objective response rates and response duration

Time: Efficacy measured at least every 8 weeks while receiving study drug

Measure: Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity

Time: PD assessed during the first 4 weeks on study

Measure: Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].

Time: PK measured during first 4 weeks on study

Measure: Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].

Time: PK measured during first 4 weeks on study

Measure: Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].

Time: PK measured during first 4 weeks on study

Measure: Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].

Time: PK measured during first 4 weeks on study

Measure: Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].

Time: PK measured during first 4 weeks on study

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---



HPO Nodes


HPO: