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A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Enzalutamide
Androgen deprivation therapy (ADT)
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Enzalutamide, Xtandi, MDV3100

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
  • Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
  • Subject is being newly initiated on Xtandi treatment (Enzalutamide).
  • Subject has an estimated life expectancy of ≥ 6 months.
  • Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

  • Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
  • Subject participating or planning to participate in any interventional drug trial during the course of this trial.
  • Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject has any condition which makes the subject unsuitable for study participation.

Sites / Locations

  • Site IN00002
  • Site IN00004
  • Site IN00008
  • Site IN00003
  • Site IN00007
  • Site IN00010
  • Site IN00001
  • Site IN00011

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzalutamide group

Arm Description

Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met

Outcomes

Primary Outcome Measures

Safety assessed by incidence of adverse events (AEs)
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
Number of participants with potentially clinically significant laboratory values.
Number of participants with physical examination abnormalities and/or AEs
Number of participants with potentially clinically significant physical examination values.
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.

Secondary Outcome Measures

Efficacy assessed by prostate-specific antigen (PSA) response rate (≥ 50% reduction from baseline)
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.

Full Information

First Posted
August 20, 2018
Last Updated
September 19, 2023
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03641560
Brief Title
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study will also evaluate the effect of enzalutamide on prostate-specific antigen (PSA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer
Keywords
Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Enzalutamide, Xtandi, MDV3100

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide group
Arm Type
Experimental
Arm Description
Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, Xtandi
Intervention Description
Enzalutamide will be administered orally
Intervention Type
Drug
Intervention Name(s)
Androgen deprivation therapy (ADT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety assessed by incidence of adverse events (AEs)
Description
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).
Time Frame
Up to 10 months
Title
Number of participants with laboratory test abnormalities and/or AEs
Description
Number of participants with potentially clinically significant laboratory values.
Time Frame
Up to 10 months
Title
Number of participants with physical examination abnormalities and/or AEs
Description
Number of participants with potentially clinically significant physical examination values.
Time Frame
Up to 10 months
Title
Number of participants with vital sign abnormalities and/or AEs
Description
Number of participants with potentially clinically significant vital sign values.
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Efficacy assessed by prostate-specific antigen (PSA) response rate (≥ 50% reduction from baseline)
Description
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.
Time Frame
Up to 10 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. Subject with established diagnosis of metastatic castration-resistant prostate carcinoma. Subject is being newly initiated on Xtandi treatment (Enzalutamide). Subject has an estimated life expectancy of ≥ 6 months. Subject agrees not to participate in another interventional study while participating in the present study. Exclusion Criteria: Subject who is not eligible to receive Xtandi as per the locally approved prescribing information. Subject participating or planning to participate in any interventional drug trial during the course of this trial. Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening. Subject has any condition which makes the subject unsuitable for study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site IN00002
City
Ahmedabad
Country
India
Facility Name
Site IN00004
City
Hubli
Country
India
Facility Name
Site IN00008
City
Kolkata
Country
India
Facility Name
Site IN00003
City
Nashik
Country
India
Facility Name
Site IN00007
City
Nashik
Country
India
Facility Name
Site IN00010
City
New Delhi
Country
India
Facility Name
Site IN00001
City
Pune
Country
India
Facility Name
Site IN00011
City
Surat
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on https://www.clinicalstudydatarequest.com/
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/

Learn more about this trial

A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

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