Pharmacokinetics of Degarelix in Chinese Patients With Pr... | NCT02468284

Studies
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

NCT02468284

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Oct 26, 2017Actual

Enrollment

15Actual

Phase

Phase 1

Conditions

Prostate Cancer

Interventions

degarelix

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

Oct 13, 2016Actual

Completion Date

Oct 10, 2017Actual

First Submitted Date

Jun 8, 2015

First Submission Date that Met QC Criteria

Jun 8, 2015

First Posted Date

Jun 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
Degarelix	Experimental		Drug: degarelix

Name	Type	Description	Arm Group Labels	Other Names
degarelix	Drug		Degarelix	Firmagon

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital (there may be other sites in this country)		Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C431566	acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided