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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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03641560
Collaborator
(none)
52
Enrollment
8
Locations
1
Arm
50.4
Anticipated Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Sep 19, 2018
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

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) [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 [Up to 10 months]

      Number of participants with potentially clinically significant laboratory values.

    3. Number of participants with physical examination abnormalities and/or AEs [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 [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) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Site IN00002 Ahmedabad India
    2 Site IN00004 Hubli India
    3 Site IN00008 Kolkata India
    4 Site IN00003 Nashik India
    5 Site IN00007 Nashik India
    6 Site IN00010 New Delhi India
    7 Site IN00001 Pune India
    8 Site IN00011 Surat India

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT03641560
    Other Study ID Numbers:
    • 9785-CL-0413
    First Posted:
    Aug 22, 2018
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Astellas Pharma Inc
    Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    Enzalutamide
    Xtandi
    MDV3100
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Androgens

    Study Results

    No Results Posted as of Aug 1, 2022