Clinical trial · Interventional
A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
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
NCT02726009CI-TRIAL-00055533completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Degarelix
- interventionNames
- Drug: Degarelix
Primary outcomes (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.