SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01086267
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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
Name: BMS-908662
Description: Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), ContinuouslyType: Drug
BMS-908662 (A1)
Name: BMS-908662
Description: Capsules, Oral, (TBD) mg, Q 12 h, ContinuouslyType: Drug
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, ContinuouslyType: Drug
Cetuximab (A1) BMS-908662 + Cetuximab (B2)
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:Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1 hr>