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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608359
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Private Limited

Tracking Information
First Submitted Date November 17, 2015
First Posted Date November 18, 2015
Last Update Posted Date February 5, 2020
Actual Study Start Date May 31, 2016
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2015)
The Number and Type of Adverse Events Reported by the Investigator or the Patient [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: November 17, 2015)
The Number and Type of Adverse Events Reported by the Investigator or the Patient [ Time Frame: up to 13 months ]
An AE is any untoward medical occurrence in a participant who receivedstudy 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.
Condition Prostate Cancer
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Drug: Abiraterone Acetate
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 Recruiting
Estimated Enrollment
 (submitted: November 17, 2015)
103
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT02608359
Other Study ID Numbers CR107096
212082PCR4021 ( Other Identifier: Johnson & Johnson Private Limited )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party Johnson & Johnson Private Limited
Study Sponsor Johnson & Johnson Private Limited
Collaborators Not Provided
Investigators
Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited
PRS Account Johnson & Johnson Private Limited
Verification Date February 2020