This is a Phase 1, Open-label, and Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Efficacy of TAK-385 in Japanese Patients With Androgen Deprivation Treatment-naïve Nonmetastatic Prostate Cancer.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02141659|
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Androgen Deprivation Treatment-naïve Nonmetastatic Prostate Cancer||Drug: TAK-385||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Randomized, Open-Label Study of TAK-385, an Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist in Japanese Patients With Androgen Deprivation Treatment-Naïve Nonmetastatic Prostate Cancer|
|Actual Study Start Date :||May 16, 2014|
|Primary Completion Date :||April 20, 2017|
|Study Completion Date :||April 20, 2017|
TAK-385 will be taken orally every morning at least 30 minutes before the first meal of the day.
320-360mg(loading dose), 40-160mg(maintenance dose)
Drug (including placebo)
- Does-limiying toxicity(DLT): Does resing phase [ Time Frame: up to 48 weeks ]
- Percentage of participants with markedly abnormal advers events [ Time Frame: up to 48 weeks ]An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug
- Percentage of participants with markedly abnormal clinical laboratory tests [ Time Frame: up to 48 weeks ]The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis.
- Percentage of participants with markedly abnormal vital signs [ Time Frame: up to 48 weeks ]Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).
- Percentage of participants with markedly abnormal 12-lead electrocardiogram (ECG) parameters [ Time Frame: up to 48 weeks ]The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan.
- Serum prostate-specific antigen (PSA) [ Time Frame: up to 48 weeks ]
- Plasma concentration of TAK-385 [ Time Frame: up to 48 weeks ]
- Serum testosterone concentration [ Time Frame: up to 48 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141659
|Sakura-shi, Chiba, Japan|
|Maebashi-shi, Gunma, Japan|
|Sapporo-shi, Hokkaido, Japan|
|Kanazawa-shi, Ishikawa, Japan|
|Yokohama-shi, Kanagawa, Japan|
|Chiyoda-ku, Tokyo, Japan|
|Study Director:||Study Manager||Takeda|