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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT02726009 (opens ClinicalTrials.gov in a new tab)Other id000201
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Overview

Status
Completed
Phase
Phase 4
Enrollment
230 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

India

Start
May 2016
Primary completion
15 May 2020
Completion
15 May 2020
First posted
1 Apr 2016 (estimated)
Last update posted
15 Dec 2021
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 4

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

    NCT02726009

    May 2016 to 15 May 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.

Interventions

  • DegarelixDrug

Arms1

  • Experimental

    Degarelix

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Frequency of adverse events

    Time frame · Up to Day 364

  2. Severity of adverse events

    Time frame · Up to Day 364

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

    Time frame · From baseline to Day 364

  4. Clinically significant changes in vital signs

    Time frame · From baseline to Day 364

Secondary outcomes(4)

  1. Cumulative probability of no Prostate Specific Antigen (PSA) failure

    Time frame · Up to Day 364

    Registry description

    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

  2. Cumulative probability of Progression Free Survival (PFS)

    Time frame · Up to Day 364

    Registry description

    PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first

  3. Change in International Prostate Symptom Score (IPSS)

    Time frame · From baseline to Day 364

  4. Change in physician's satisfaction score

    Time frame · From baseline to Day 364

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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