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A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Has given written informed consent before any study-related activity is performed
  • Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
  • Age greater than or equal to 18 years and less than 80 years
  • Advanced hormone-dependent prostate cancer without any other clinically significant disorder
  • Easten Cooperative Oncology Group score ≤ 2
  • PSA ≥ 2 ng/mL at screening
  • Life expectancy of at least 12 months as per the investigator's judgement

Exclusion Criteria:

  • Previous or concurrent hormonal management of prostate cancer
  • Contraindication for prescription of Firmagon®
  • Concurrent treatment with a 5-α-reductase inhibitor
  • Considered as a candidate for curative therapy
  • History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
  • QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
  • Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
  • Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
  • Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
  • Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections

Sites / Locations

  • S. P Medical College and AG of Hospitals
  • Krishna Institute of Medical Sciences
  • Bodyline Hospitals
  • HCG Multi Specialty Hospital
  • Shalby Hospital
  • HealthCare Global Enterprises Limited
  • KLE's Dr. Prabhakar Kore Hospital & MRC
  • Apollo Speciality Hospital
  • Rajiv Gandhi Cancer Institute and Research Centre
  • Muljibhai Patel Urological Hospital
  • CHL Hospital
  • SMS Medical College & Attached Hospital's
  • Tata Medical Center
  • King's George Medical University
  • Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
  • Tata Memorial Hospital
  • Government Medical College and Super Specialty Hospital
  • Rml & Pgimer
  • Aman Hospital and Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Outcomes

Primary Outcome Measures

Frequency of adverse events
Severity of adverse events
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
Clinically significant changes in vital signs

Secondary Outcome Measures

Cumulative probability of no Prostate Specific Antigen (PSA) failure
PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart
Cumulative probability of Progression Free Survival (PFS)
PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first
Change in International Prostate Symptom Score (IPSS)
Change in physician's satisfaction score

Full Information

First Posted
March 29, 2016
Last Updated
December 14, 2021
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02726009
Brief Title
A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
Official Title
An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
Firmagon®
Primary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
Up to Day 364
Title
Severity of adverse events
Time Frame
Up to Day 364
Title
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
Time Frame
From baseline to Day 364
Title
Clinically significant changes in vital signs
Time Frame
From baseline to Day 364
Secondary Outcome Measure Information:
Title
Cumulative probability of no Prostate Specific Antigen (PSA) failure
Description
PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart
Time Frame
Up to Day 364
Title
Cumulative probability of Progression Free Survival (PFS)
Description
PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first
Time Frame
Up to Day 364
Title
Change in International Prostate Symptom Score (IPSS)
Time Frame
From baseline to Day 364
Title
Change in physician's satisfaction score
Time Frame
From baseline to Day 364

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has given written informed consent before any study-related activity is performed Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment Age greater than or equal to 18 years and less than 80 years Advanced hormone-dependent prostate cancer without any other clinically significant disorder Easten Cooperative Oncology Group score ≤ 2 PSA ≥ 2 ng/mL at screening Life expectancy of at least 12 months as per the investigator's judgement Exclusion Criteria: Previous or concurrent hormonal management of prostate cancer Contraindication for prescription of Firmagon® Concurrent treatment with a 5-α-reductase inhibitor Considered as a candidate for curative therapy History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment) Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
S. P Medical College and AG of Hospitals
City
Bikaner
State/Province
Rajasthan
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
State/Province
Telangana
Country
India
Facility Name
Bodyline Hospitals
City
Ahmedabad
Country
India
Facility Name
HCG Multi Specialty Hospital
City
Ahmedabad
Country
India
Facility Name
Shalby Hospital
City
Ahmedabad
Country
India
Facility Name
HealthCare Global Enterprises Limited
City
Bangalore
Country
India
Facility Name
KLE's Dr. Prabhakar Kore Hospital & MRC
City
Belgaum
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
Delhi
Country
India
Facility Name
Muljibhai Patel Urological Hospital
City
Gujrat
Country
India
Facility Name
CHL Hospital
City
Indore
Country
India
Facility Name
SMS Medical College & Attached Hospital's
City
Jaipur
Country
India
Facility Name
Tata Medical Center
City
Kolkata
Country
India
Facility Name
King's George Medical University
City
Lucknow
Country
India
Facility Name
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
City
Mumbai
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
Country
India
Facility Name
Government Medical College and Super Specialty Hospital
City
Nagpur
Country
India
Facility Name
Rml & Pgimer
City
New Delhi
Country
India
Facility Name
Aman Hospital and Research Center
City
Vadodara
Country
India

12. IPD Sharing Statement

Learn more about this trial

A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

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