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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

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
Prostate Cancer 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.

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Study Type : Observational
Estimated Enrollment : 103 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
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.
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

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): NCT02608359


Contacts
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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

Locations
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India
Healthcare Global (HCG) Hospital Recruiting
Bangalore, India, 560027
Tata Memorial Hospital Withdrawn
Bombay N/a, India, 400012
Rajiv Gandhi Cancer Institute & Research Centre Recruiting
Delhi, India, 110085
Christian medical Withdrawn
Ludhiana, Punjab, India, 141008
P. D. Hinduja National Hospital and Research Center Withdrawn
Mumbai, India, 400016
Max Super specialty Recruiting
New Delhi, India, 110017
Indraprastha Apollo Hospital Recruiting
New Delhi, India, 1100776
Sponsors and Collaborators
Johnson & Johnson Private Limited
Investigators
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Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited

Additional Information:
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Responsible Party: Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier: NCT02608359    
Other Study ID Numbers: CR107096
212082PCR4021 ( Other Identifier: Johnson & Johnson Private Limited )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Johnson & Johnson Private Limited:
Post-Marketing Surveillance
Abiraterone Acetate
Zytiga
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors