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

NCT02726009 | Completed Phase 4

• 1 other identifier: 000201
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 19

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Frequency of adverse events

  Up to Day 364

• Severity of adverse events

  Up to Day 364

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

  From baseline to Day 364

• Clinically significant changes in vital signs

  From baseline to Day 364

Secondary Outcomes (4)

• Cumulative probability of no Prostate Specific Antigen (PSA) failure

  Up to Day 364

• Cumulative probability of Progression Free Survival (PFS)

  Up to Day 364

• Change in International Prostate Symptom Score (IPSS)

  From baseline to Day 364

• Change in physician's satisfaction score

  From baseline to Day 364

Study Arms (1)

Degarelix

EXPERIMENTAL

Drug: Degarelix

Interventions

Degarelix DRUG

Also known as: Firmagon®

Degarelix

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (19)

S. P Medical College and AG of Hospitals

Bikaner, Rajasthan, India

Location

Krishna Institute of Medical Sciences

Secunderabad, Telangana, India

Location

Bodyline Hospitals

Ahmedabad, India

Location

HCG Multi Specialty Hospital

Ahmedabad, India

Location

Shalby Hospital

Ahmedabad, India

Location

HealthCare Global Enterprises Limited

Bangalore, India

Location

KLE's Dr. Prabhakar Kore Hospital & MRC

Belagavi, India

Location

Apollo Speciality Hospital

Chennai, India

Location

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, India

Location

Muljibhai Patel Urological Hospital

Gujrāt, India

Location

CHL Hospital

Indore, India

Location

SMS Medical College & Attached Hospital's

Jaipur, India

Location

Tata Medical Center

Kolkata, India

Location

King's George Medical University

Lucknow, India

Location

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

Mumbai, India

Location

Tata Memorial Hospital

Mumbai, India

Location

Government Medical College and Super Specialty Hospital

Nagpur, India

Location

Rml & Pgimer

New Delhi, India

Location

Aman Hospital and Research Center

Vadodara, India

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: May 1, 2016
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

IN (19)