This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
TAK-441 will be administered as an oral tablet as follows: Patients enrolled in the dose escalation cohorts will receive: * A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed * Continuous daily dosing on Days 8 through 28 in Cycle 1 * In subsequent cycles, continuous daily dosing over 21 days, repeated continuously Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle
Mayo Clinic
Scottsdale, Arizona, United States
Premiere Oncology, A Medical Corporation
Santa Monica, California, United States
Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies
Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
Time frame: From first dose of TAK-441 through 30 days after the last dose of TAK-441
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
Including but not limited to maximum plasma concentration (Cmax), first time to plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC)
Time frame: Sampling during Cycle 1 (Days 1-28)
Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
Time frame: Cycle 1 Day 22
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
Time frame: Cycle 1 Day 15
Antitumor activity of TAK-441 administered as a single-agent therapy based on investigators' assessments of tumor response in patients who have advanced basal cell carcinoma
Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time frame: Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
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