The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.
The objective of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naive participants with non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising (MRD) phase and Part B, an expansion phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
TAK-385 Tablets.
Unnamed facility
Sakura-shi, Chiba, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kanazawa, Ishikawa-ken, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Part A: Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose.
Time frame: From treatment initiation until Day 28
Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Part B: Number of Participants Reporting One or More TEAE
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
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Unnamed facility
Chiyoda-ku, Tokyo, Japan
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase \[GOT\]) High, creatine kinase (CK) (creatine phosphokinase \[CPK\]) High, prothrombin time (PT)-international normalized ratio (INR) High.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Here "BP" is blood pressure.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28
Time frame: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose
Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28
Time frame: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose
Part A: Serum Testosterone Concentrations for TAK-385
Time frame: Up to Day 35
Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF)
Time frame: Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)
Part B: Plasma Concentration of Unchanged TAK-385
Time frame: Up to Week 49 Day 1
Part B: Serum Testosterone Concentrations for TAK-385
Time frame: Up to Week 97 Day 1