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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Jul 2015
Shorter than P25 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedOctober 26, 2017
October 1, 2017
1.3 years
June 8, 2015
October 25, 2017
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (1)
Plasma trough levels of degarelix
At Days 28, 56, 168 and 196
Study Arms (1)
Degarelix
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital (there may be other sites in this country)
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 10, 2015
Study Start
July 1, 2015
Primary Completion
October 13, 2016
Study Completion
October 10, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10