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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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.
Wayne State University Karmanos Cancer Institute
Detriot, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733
Time frame: 12 months
Pharmacokinetic characterization of TAK-733
Time frame: 12 months
Effect of food on the pharmacokinetics of TAK-733
Time frame: 12 months
Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies
Time frame: 12 months
Antitumor activity of TAK-733 in melanoma patients
Time frame: 12 months
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