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

NCT02015871 | Completed Phase 3

• 1 other identifier: 000006A
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Number and percentage of patients with Adverse Events (AEs)

  Baseline to Month 26

• Change in ECG parameters

  Baseline to Month 26

• Change in body weight and vital signs

  Baseline to Month 26

• Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)

  Baseline to Month 26

Secondary Outcomes (3)

• Change in testosterone levels

  Baseline to Month 26

• Change in prostate-specific antigen (PSA) levels

  Baseline to Month 26

• Cumulative probability of no PSA failure

  Baseline to Month 26

Study Arms (1)

Degarelix

EXPERIMENTAL

Drug: Degarelix

Interventions

Degarelix DRUG

Degarelix

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has been withdrawn/discontinued from the 000006 trial.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Peking University People's Hospital (there may be multiple sites in this country)

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 18, 2023

Record last verified: 2017-08

Locations

CN (1)