Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: degarelix

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix	Drug: degarelix; Other Names: Firmagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration observed (Cmax)	Day 0 - 196
Time of Cmax after subcutaneous administration (Tmax)	Day 0 - 196
Maximum plasma concentration observed (Cmax)	Day 0 - 28
Maximum plasma concentration observed (Cmax)	Day 168 - 196
Time of Cmax after subcutaneous administration (Tmax)	Day 0 - 28
Time of Cmax after subcutaneous administration (Tmax)	Day 168 - 196
Area under the plasma concentration-time curve during a drug dosing interval (AUC)	Day 0 - 28
Area under the plasma concentration-time curve during a drug dosing interval (AUC)	Day 168 - 196

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma trough levels of degarelix	At Days 28, 56, 168 and 196

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): October 13, 2016
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 000200