Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: degarelix

• Registration Number: NCT02468284
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-10
• Study Start: 2015-07
• Primary Completion: 2016-10-13
• Status Verified: 2017-10
• Study Completion: 2017-10-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Degarelix	degarelix	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration observed (Cmax)	Day 168 - 196
Time of Cmax after subcutaneous administration (Tmax)	Day 168 - 196
Area under the plasma concentration-time curve during a drug dosing interval (AUC)	Day 168 - 196

Secondary Outcome Measures

Name	Time	Method
Plasma trough levels of degarelix	At Days 28, 56, 168 and 196

Trial Locations

Locations (1)

Peking University Third Hospital (there may be other sites in this country); 🇨🇳 Beijing, China