Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468284
• Other study ID #: 000200
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2015
• Last updated: October 25, 2017
• Start date: July 2015
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 10, 2017
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• degarelix

Locations

Country	Name	City	State
China	Peking University Third Hospital (there may be other sites in this country)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration observed (Cmax)		Day 0 - 196
Primary	Time of Cmax after subcutaneous administration (Tmax)		Day 0 - 196
Primary	Maximum plasma concentration observed (Cmax)		Day 0 - 28
Primary	Maximum plasma concentration observed (Cmax)		Day 168 - 196
Primary	Time of Cmax after subcutaneous administration (Tmax)		Day 0 - 28
Primary	Time of Cmax after subcutaneous administration (Tmax)		Day 168 - 196
Primary	Area under the plasma concentration-time curve during a drug dosing interval (AUC)		Day 0 - 28
Primary	Area under the plasma concentration-time curve during a drug dosing interval (AUC)		Day 168 - 196
Secondary	Plasma trough levels of degarelix		At Days 28, 56, 168 and 196