An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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Official title:

An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015871
• Other study ID #: 000006A
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient

• Has completed the 000006 trial

Exclusion Criteria:

• Has been withdrawn/discontinued from the 000006 trial.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

Locations

Country	Name	City	State
China	Peking University People's Hospital (there may be multiple sites in this country)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with Adverse Events (AEs)		Baseline to Month 26
Primary	Change in ECG parameters		Baseline to Month 26
Primary	Change in body weight and vital signs		Baseline to Month 26
Primary	Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)		Baseline to Month 26
Secondary	Change in testosterone levels		Baseline to Month 26
Secondary	Change in prostate-specific antigen (PSA) levels		Baseline to Month 26
Secondary	Cumulative probability of no PSA failure	PSA failure is defined as two consecutive (at least two weeks apart) increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either trial 000006 or trial 000006A)	Baseline to Month 26