Open-Label, Randomised Parallel-Group Study

This study has been withdrawn prior to enrollment.

(Terminated due to awaiting data from Phase II study.)

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00728533

First received: January 18, 2008

Last updated: March 17, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2008

Last Updated Date

March 17, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00728533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
To evaluate pharmacokinetic response. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
To compare safety and tolerability profiles of different degarelix three-month dosing regimens. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Open-Label, Randomised Parallel-Group Study

Official Title ^ICMJE

The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.

Brief Summary

An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: Degarelix

Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

Study Arm (s)

Experimental: 1
- Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
- Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
Intervention: Drug: Degarelix
Experimental: 2
- Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
- Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
Intervention: Drug: Degarelix

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
Screening PSA level of =2 ng/mL. ECOG score of =2.
Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
Serum levels of testosterone, LH, FSH, and PSA over time.
Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Plasma levels of degarelix over time.
Frequency and severity of adverse events.
Clinically significant changes in laboratory safety parameters.
Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00728533

Other Study ID Numbers ^ICMJE

FE200486 CS26, 2007-006055-39

Has Data Monitoring Committee

Yes

Responsible Party

Clinical Development Support, Ferring Pharmaceuticals

Study Sponsor ^ICMJE

Ferring Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

Information Provided By

Ferring Pharmaceuticals

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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