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

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02726009
Collaborator
(none)
230
Enrollment
19
Locations
1
Arm
48.5
Actual Duration (Months)
12.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
May 15, 2020
Actual Study Completion Date :
May 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Degarelix

Drug: Degarelix
Other Names:
  • Firmagon®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of adverse events [Up to Day 364]

    2. Severity of adverse events [Up to Day 364]

    3. Clinically significant changes in laboratory values (hematology and clinical biochemistry) [From baseline to Day 364]

    4. Clinically significant changes in vital signs [From baseline to Day 364]

    Secondary Outcome Measures

    1. Cumulative probability of no Prostate Specific Antigen (PSA) failure [Up to Day 364]

      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

    2. Cumulative probability of Progression Free Survival (PFS) [Up to Day 364]

      PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first

    3. Change in International Prostate Symptom Score (IPSS) [From baseline to Day 364]

    4. Change in physician's satisfaction score [From baseline to Day 364]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 S. P Medical College and AG of Hospitals Bikaner Rajasthan India
    2 Krishna Institute of Medical Sciences Secunderabad Telangana India
    3 Bodyline Hospitals Ahmedabad India
    4 HCG Multi Specialty Hospital Ahmedabad India
    5 Shalby Hospital Ahmedabad India
    6 HealthCare Global Enterprises Limited Bangalore India
    7 KLE's Dr. Prabhakar Kore Hospital & MRC Belgaum India
    8 Apollo Speciality Hospital Chennai India
    9 Rajiv Gandhi Cancer Institute and Research Centre Delhi India
    10 Muljibhai Patel Urological Hospital Gujrat India
    11 CHL Hospital Indore India
    12 SMS Medical College & Attached Hospital's Jaipur India
    13 Tata Medical Center Kolkata India
    14 King's George Medical University Lucknow India
    15 Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Mumbai India
    16 Tata Memorial Hospital Mumbai India
    17 Government Medical College and Super Specialty Hospital Nagpur India
    18 Rml & Pgimer New Delhi India
    19 Aman Hospital and Research Center Vadodara India

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02726009
    Other Study ID Numbers:
    • 000201
    First Posted:
    Apr 1, 2016
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 15, 2021