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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Degarelix

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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Has been withdrawn/discontinued from the 000006 trial.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Outcomes

Primary Outcome Measures

Number and percentage of patients with Adverse Events (AEs)

Change in ECG parameters

Change in body weight and vital signs

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

Secondary Outcome Measures

Change in testosterone levels

Change in prostate-specific antigen (PSA) levels

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)

Full Information

NCT ID

NCT02015871

First Posted

December 13, 2013

Last Updated

June 15, 2023

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02015871

Brief Title

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

Acronym

PandaExtension

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 1, 2017 (Actual)

Study Completion Date

August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Degarelix

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Degarelix

Primary Outcome Measure Information:

Title

Number and percentage of patients with Adverse Events (AEs)

Time Frame

Baseline to Month 26

Title

Change in ECG parameters

Time Frame

Baseline to Month 26

Title

Change in body weight and vital signs

Time Frame

Baseline to Month 26

Title

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

Time Frame

Baseline to Month 26

Secondary Outcome Measure Information:

Title

Change in testosterone levels

Time Frame

Baseline to Month 26

Title

Change in prostate-specific antigen (PSA) levels

Time Frame

Baseline to Month 26

Title

Cumulative probability of no PSA failure

Description

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)

Time Frame

Baseline to Month 26

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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