A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
NCT ID: NCT02726009
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
230 participants
INTERVENTIONAL
2016-05-31
2020-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Degarelix
Degarelix
Interventions
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Degarelix
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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S. P Medical College and AG of Hospitals
Bikaner, Rajasthan, India
Krishna Institute of Medical Sciences
Secunderabad, Telangana, 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
Belagavi, , India
Apollo Speciality Hospital
Chennai, , India
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, , India
Muljibhai Patel Urological Hospital
Gujrāt, , 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
Aman Hospital and Research Center
Vadodara, , India
Countries
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Other Identifiers
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000201
Identifier Type: -
Identifier Source: org_study_id