Back to resultsPharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
degarelix
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Peking University Third Hospital (there may be other sites in this country)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Degarelix
Arm Description
Outcomes
Primary Outcome Measures
Maximum plasma concentration observed (Cmax)
Time of Cmax after subcutaneous administration (Tmax)
Maximum plasma concentration observed (Cmax)
Maximum plasma concentration observed (Cmax)
Time of Cmax after subcutaneous administration (Tmax)
Time of Cmax after subcutaneous administration (Tmax)
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Secondary Outcome Measures
Plasma trough levels of degarelix
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02468284
Brief Title
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
October 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
Firmagon
Primary Outcome Measure Information:
Title
Maximum plasma concentration observed (Cmax)
Time Frame
Day 0 - 196
Title
Time of Cmax after subcutaneous administration (Tmax)
Time Frame
Day 0 - 196
Title
Maximum plasma concentration observed (Cmax)
Time Frame
Day 0 - 28
Title
Maximum plasma concentration observed (Cmax)
Time Frame
Day 168 - 196
Title
Time of Cmax after subcutaneous administration (Tmax)
Time Frame
Day 0 - 28
Title
Time of Cmax after subcutaneous administration (Tmax)
Time Frame
Day 168 - 196
Title
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Time Frame
Day 0 - 28
Title
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Time Frame
Day 168 - 196
Secondary Outcome Measure Information:
Title
Plasma trough levels of degarelix
Time Frame
At Days 28, 56, 168 and 196
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital (there may be other sites in this country)
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
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