SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00948467
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and
maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The
expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in
patients with advanced metastatic melanoma.
NCT00948467 Advanced Non-hematologic Malignancies Advanced Metastatic Melanoma
1 Interventions
Name: TAK-733
Description: The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
Type: Drug
Primary Outcomes
Measure: Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733 Time: 12 months
Measure: Pharmacokinetic characterization of TAK-733 Time: 12 months
Secondary Outcomes
Measure: Effect of food on the pharmacokinetics of TAK-733 Time: 12 months
Measure: Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies Time: 12 months
Measure: Antitumor activity of TAK-733 in melanoma patients Time: 12 months
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
- Melanoma patients should have the V600E BRAF mutation status of their tumor
documented, if available, and tumor tissue must be provided for confirmatory
genotyping by a central laboratory. --- V600E ---