SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT01582997

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open-label, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of GSK2118436 in Japanese Subjects With BRAF V600 Mutation Positive Solid Tumors

BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule.

NCT01582997 Cancer

1 Interventions

Name: GSK2118436

Description: Dose escalation with GSK2118436 may proceed until the overseas recommended phase III dose.

Type: Drug

Dose Escalation Part

Primary Outcomes

Description: Adverse Events will be graded by the investigator according to the NCI-CTCAE (version 4.0)

Measure: Number of participants with adverse events as a measure of safety and tolerability

Time: First 28 days for Dose-limiting toxicity, Adverse Events for 1 year

Secondary Outcomes

Measure: Pharmacokinetics (PK) parameters of GSK2118436 and its metabolites including blood concentration, Cmax and AUC

Time: For 1 year

Measure: Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time: For 1 year

Measure: Serum levels of cytokines

Time: For 1 year

Measure: Expression levels of pERK and Ki67 in tumor tissues if possible

Time: For 1 year

Measure: Gene mutation in tumor tissues, including BRAF and KRAS

Time: For 1 year

Purpose: Treatment

Single Group Assignment

There is one SNP


1 V600E

- Subjects must have BRAF V600E or K mutant positive tumors. --- V600E ---

HPO Nodes