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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726009
• Other study ID #: 000201
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: May 15, 2020

Study information

• Verified date: December 2021
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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-a-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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

Locations

Country	Name	City	State
India	Bodyline Hospitals	Ahmedabad
India	HCG Multi Specialty Hospital	Ahmedabad
India	Shalby Hospital	Ahmedabad
India	HealthCare Global Enterprises Limited	Bangalore
India	KLE's Dr. Prabhakar Kore Hospital & MRC	Belgaum
India	S. P Medical College and AG of Hospitals	Bikaner	Rajasthan
India	Apollo Speciality Hospital	Chennai
India	Rajiv Gandhi Cancer Institute and Research Centre	Delhi
India	Muljibhai Patel Urological Hospital	Gujrat
India	CHL Hospital	Indore
India	SMS Medical College & Attached Hospital's	Jaipur
India	Tata Medical Center	Kolkata
India	King's George Medical University	Lucknow
India	Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute	Mumbai
India	Tata Memorial Hospital	Mumbai
India	Government Medical College and Super Specialty Hospital	Nagpur
India	Rml & Pgimer	New Delhi
India	Krishna Institute of Medical Sciences	Secunderabad	Telangana
India	Aman Hospital and Research Center	Vadodara

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		Up to Day 364
Primary	Severity of adverse events		Up to Day 364
Primary	Clinically significant changes in laboratory values (hematology and clinical biochemistry)		From baseline to Day 364
Primary	Clinically significant changes in vital signs		From baseline to Day 364
Secondary	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	Up to Day 364
Secondary	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	Up to Day 364
Secondary	Change in International Prostate Symptom Score (IPSS)		From baseline to Day 364
Secondary	Change in physician's satisfaction score		From baseline to Day 364