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Report for Clinical Trial NCT01582997
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
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.
Description: Dose escalation with GSK2118436 may proceed until the overseas recommended phase III dose.
Group Labels: 1 Dose Escalation Part
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
Single Group Assignment
There is one SNP
- Subjects must have BRAF V600E or K mutant positive tumors. --- V600E ---