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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

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

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:
Neoplasm of the large intestine
Genes 120
FLCN SDHC MLH1 PMS2 APC EPCAM SDHC PALLD SRC BUB1 APC GREM1 NTHL1 PMS1 PTEN SDHB MSH6 APC KIT SDHD KRAS BMPR1A FAN1 CTNNB1 MSH3 POLD1 KRAS RNF43 KEAP1 DICER1 DLC1 BMPR1A MSH2 MSH6 PIK3CA CDKN2A FGFR3 BMPR1A MUTYH PIK3CA BMPR1A EP300 FOXE1 ENG SMAD7 AXIN2 CHEK2 MLH1 RPS20 BRCA1 RPS19 PRKAR1A APC GPR35 MLH1 AKT1 POLE SMAD4 KIT TP53 TRIP13 COL14A1 MDM2 SMAD4 POLE BRCA2 AKT1 MSH6 HABP2 NRAS MUTYH BUB1B DOCK8 TGFBR2 STK11 AXIN2 EPCAM BUB3 DCC AXIN2 TCF4 KLLN MSH2 APC TP53 SEC23B PTEN TGFBR2 SEMA4A POLD1 PIK3CA PDGFRA MINPP1 APC SH3KBP1 BMPR1A TP53 BUB1 AAGAB SMAD4 BMPR1A MST1 MLH3 MSH2 PALB2 FLCN SDHA PMS2 SDHB BUB1B MSH2 MLH1 CEP57 MLH3 TP53 PTPRJ PMS1 APC CDKN2A APC