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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

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ClinicalTrials.gov Identifier: NCT03641560
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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.



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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.

Information from the National Library of Medicine

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): NCT03641560


Contacts
Contact: Astellas Pharma Inc. +81-3-3244-0512 astellas.registration@astellas.com

Locations
India
Site IN00004 Recruiting
Hubli, India
Site IN00003 Recruiting
Nashik, India
Site IN00007 Recruiting
Nashik, India
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03641560     History of Changes
Other Study ID Numbers: 9785-CL-0413
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs