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Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

NCT ID: NCT02468284

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-10-10

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Degarelix

Group Type EXPERIMENTAL

degarelix

Intervention Type DRUG

Interventions

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degarelix

Intervention Type DRUG

Other Intervention Names

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Firmagon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Peking University Third Hospital (there may be other sites in this country)

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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000200

Identifier Type: -

Identifier Source: org_study_id