Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

Ferring

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02468284

000200

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Degarelix

Experimental group

Treatment:

Drug: degarelix