Clinical trial NCT02726009: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 230
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency of adverse events
timeFrame: Up to Day 364
measure: Severity of adverse events
timeFrame: Up to Day 364
measure: Clinically significant changes in laboratory values (hematology and clinical biochemistry)
timeFrame: From baseline to Day 364
measure: Clinically significant changes in vital signs
timeFrame: From baseline to Day 364
Secondary outcomes:
measure: Cumulative probability of no Prostate Specific Antigen (PSA) failure
timeFrame: Up to Day 364
measure: Cumulative probability of Progression Free Survival (PFS)
timeFrame: Up to Day 364
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: From baseline to Day 364
measure: Change in physician's satisfaction score
timeFrame: From baseline to Day 364
Other outcomes:
Locations:
city: Bikaner
country: India
facility: S. P Medical College and AG of Hospitals
state: Rajasthan
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
state: Telangana
city: Ahmedabad
country: India
facility: Bodyline Hospitals
city: Ahmedabad
country: India
facility: HCG Multi Specialty Hospital
city: Ahmedabad
country: India
facility: Shalby Hospital
city: Bangalore
country: India
facility: HealthCare Global Enterprises Limited
city: Belgaum
country: India
facility: KLE's Dr. Prabhakar Kore Hospital & MRC
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Gujrat
country: India
facility: Muljibhai Patel Urological Hospital
city: Indore
country: India
facility: CHL Hospital
city: Jaipur
country: India
facility: SMS Medical College & Attached Hospital's
city: Kolkata
country: India
facility: Tata Medical Center
city: Lucknow
country: India
facility: King's George Medical University
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Nagpur
country: India
facility: Government Medical College and Super Specialty Hospital
city: New Delhi
country: India
facility: Rml & Pgimer
city: Vadodara
country: India
facility: Aman Hospital and Research Center
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: