An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer (PandaExtension)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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- Has been withdrawn/discontinued from the 000006 trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
206 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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