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

Ferring Pharmaceuticals19 sites in 1 country230 target enrollmentMay 2016

ConditionsProstate Cancer

InterventionsDegarelix

DrugsDegarelix

Overview

Phase: Phase 4
Intervention: Degarelix
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Enrollment: 230
Locations: 19
Primary Endpoint: Frequency of adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

May 15, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

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

Arms & Interventions

Degarelix

Intervention: Degarelix

Outcomes

Primary Outcomes

Frequency of adverse events

Time Frame: Up to Day 364

Severity of adverse events

Time Frame: Up to Day 364

Clinically significant changes in laboratory values (hematology and clinical biochemistry)

Time Frame: From baseline to Day 364

Clinically significant changes in vital signs

Time Frame: From baseline to Day 364

Secondary Outcomes

Change in International Prostate Symptom Score (IPSS)(From baseline to Day 364)
Change in physician's satisfaction score(From baseline to Day 364)
Cumulative probability of no Prostate Specific Antigen (PSA) failure(Up to Day 364)
Cumulative probability of Progression Free Survival (PFS)(Up to Day 364)