A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer

Sponsor
Johnson & Johnson Private Limited (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02608359
Collaborator
(none)
0
3
72
0
0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of abiraterone acetate in Indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved prescribing information.

Condition or Disease Intervention/Treatment Phase
  • Drug: Abiraterone Acetate

Detailed Description

This is a prospective (the participants are identified and then followed forward in time for the outcome of the study), multicenter (when more than one hospital or medical school team work on a medical research study), post-marketing surveillance ([PMS], surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale) study. The study will consist of Screening and Enrolment Visit (Day 1) and Follow-up Period (12 months). For each participant, the follow-up visits will be conducted as per routine clinical practice at month 3, 6 and 9. The End-of-Study (EOS) Visit will be conducted after the completion of 12-months abiraterone acetate (Zytiga) and a telephonic follow-up will be conducted 30 days after the EOS Visit. The total duration of the study will be 13 months. Participants receiving abiraterone acetate as per locally approved prescribing information will be enrolled in the PMS. The use of abiraterone acetate will follow dosing and frequency stipulated in the locally approved prescribing information. Participants will be monitored during treatment of abiraterone acetate and up to 30 days post treatment for collection of adverse events. Participants' safety will be monitored throughout the study.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety of Zytiga (Abiraterone Acetate Tablets 250 mg) in Indian Patients With Metastatic, Castration Resistant Prostate Cancer as Per Locally Approved Prescribing Information
Actual Study Start Date :
May 31, 2016
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Abiraterone Acetate (Zytiga) Post-marketing Surveillance (PMS)

This is an observational study and participants will not receive any intervention as a part of this study. All prospective participants who will be prescribed abiraterone acetate tablets 250 milligram (mg) treatment based on independent clinical judgment and as per locally approved prescribing information will be enrolled in the PMS. Participants will be exclusively observed for safety.

Drug: Abiraterone Acetate
This is an observational study and participants will not receive any intervention as a part of this study. All prospective participants who will be prescribed abiraterone acetate tablets 250 milligram (mg) treatment based on independent clinical judgment and as per locally approved prescribing information will be enrolled in the PMS. Participants will be exclusively observed for safety.

Outcome Measures

Primary Outcome Measures

  1. The Number and Type of Adverse Events Reported by the Investigator or the Patient [up to 13 months]

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The severity of adverse events will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants with established diagnosis of metastatic castration-resistant prostate carcinoma

  • Being newly initiated on Zytiga treatment (abiraterone acetate tablets 250 mg) based on independent clinical judgment of treating physicians as per locally approved prescribing information

  • Willing to provide written informed consent indicating that they understand the purpose and are willing to participate in the post-marketing surveillance (PMS)

Exclusion Criteria:
  • Participants who are not eligible to receive Zytiga as per the locally approved prescribing information

  • Participants participating or planning to participate in any interventional drug trial during the course of this PMS

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bangalore India
2 Delhi India
3 New Delhi India

Sponsors and Collaborators

  • Johnson & Johnson Private Limited

Investigators

  • Study Director: Johnson & Johnson Private Limited Clinical Trial, Johnson & Johnson Private Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier:
NCT02608359
Other Study ID Numbers:
  • CR107096
  • 212082PCR4021
First Posted:
Nov 18, 2015
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Keywords provided by Johnson & Johnson Private Limited
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022