A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03641560|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration Resistant Prostate Cancer||Drug: Enzalutamide Drug: Androgen deprivation therapy (ADT)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase 4, Open-label, Single-arm, Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy|
|Actual Study Start Date :||September 19, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Enzalutamide group
Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met
Enzalutamide will be administered orally
Drug: Androgen deprivation therapy (ADT)
All participants will be required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy
- Safety assessed by incidence of adverse events (AEs) [ Time Frame: Up to 10 months ]An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) guidelines (Version 4.03).
- Number of participants with laboratory test abnormalities and/or AEs [ Time Frame: Up to 10 months ]Number of participants with potentially clinically significant laboratory values.
- Number of participants with physical examination abnormalities and/or AEs [ Time Frame: Up to 10 months ]Number of participants with potentially clinically significant physical examination values.
- Number of participants with vital sign abnormalities and/or AEs [ Time Frame: Up to 10 months ]Number of participants with potentially clinically significant vital sign values.
- Efficacy assessed by prostate-specific antigen (PSA) response rate (≥ 50% reduction from baseline) [ Time Frame: Up to 10 months ]PSA response ≥ 50% is defined as ≥ 50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641560
|Contact: Astellas Pharma Inc.||+email@example.com|
|Study Director:||Central Contact||Astellas Pharma Inc|