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

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

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).

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: Enzalutamide Drug: Androgen deprivation therapy (ADT) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : November 30, 2021
Estimated Study Completion Date : November 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Enzalutamide group
Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met
 Drug: Enzalutamide
Enzalutamide will be administered orally
Other Names:
  • MDV3100
  • Xtandi

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
Outcome Measures
Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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India
Site IN00002
Ahmedabad, India
Site IN00004
Hubli, India
Site IN00008
Kolkata, India
Site IN00003
Nashik, India
Site IN00007
Nashik, India
Site IN00010
New Delhi, India
Site IN00001
Pune, India
Site IN00011
Surat, India
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma Inc
Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2018) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration Resistant Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    Enzalutamide will be administered orally
    Other Names:
    • MDV3100
    • Xtandi
  • 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
Study Arms  ICMJE Experimental: Enzalutamide group
Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met
Interventions:
  • Drug: Enzalutamide
  • Drug: Androgen deprivation therapy (ADT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 23, 2019) 		52
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2018) 		50
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641560
Other Study ID Numbers  ICMJE 9785-CL-0413
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
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.
URL: https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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