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Report for Clinical Trial NCT01086267
 Developed by Shray Alag, 2020-2021.
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), 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:  3  BMS-908662 + Cet  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 ---