Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2017-10-10
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

Inclusion Criteria:

• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated

• Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening

• Has a screening serum testosterone level >150 ng/dL

• Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit

• Is currently treated with a 5-alpha reductase inhibitor

• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy

• Is in need of neoadjuvant hormonal therapy

• Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy