SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01086267

Developed by Shray Alag, 2019.
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

BMS-908662 (A1)

Name: BMS-908662

Description: Capsules, Oral, (TBD) mg, Q 12 h, Continuously

Type: 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, Continuously

Type: 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