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A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Degarelix 80 mg / Degarelix 80 mg (Drug); Degarelix 160 mg / Degarelix 160 mg (Drug); Leuprolide 7.5 mg / Degarelix 80 mg (Drug); Leuprolide 7.5 mg / Degarelix 160 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Summary

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Clinical Details

Official title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

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

Primary outcome:

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Secondary outcome:

Percentage of Participants With no Prostate-specific Antigen (PSA) Progression

Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards

Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56

Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56

Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56

Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion/Exclusion Criteria:

- Patients with histologically proven prostate cancer of all stages in whom endocrine

treatment is indicated.

- Signed informed consent

- The patients must have completed the FE 200486 CS21 Study.

Locations and Contacts

Can-Med Clinical Research Inc, Victoria, Canada

Urocentrum Brno, Brno, Czech Republic

UROHELP - Bozetechova, Brno, Czech Republic

Nemocnice Jindrichuv Hradec, a.s., Jindrichuv Hradec, Czech Republic

Fakultni Nemocnice Olomouc, Olomouc, Czech Republic

Slezska nemocnice, Opava, Czech Republic

Fakultni nemocnice v Motole, Prague5, Prague, Czech Republic

Vseobecna fakultni nemocnice v Praze, Prague2, Prague, Czech Republic

Klinikum Mannheim Universitätsklinikum GmbH, Mannheim, Germany

Klinikum der Universität Regensburg, Regensburg, Germany

Fövárosi Önkormányzat uzsoki utcai Kórház, Budapest, Hungary

Dombóvári Szent Lukács Egészségügyi Kht., Dombóvár, Hungary

Petz Aladár Megyei Oktató Kórház, Györ, Hungary

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc, Hungary

Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft, Miskolc, Hungary

Pécsi Tudományegyetem, Pécs, Hungary

Investigational Site, Szeged, Hungary

Investigational Site, Acapulco, Mexico

Hospital Christus Muguerza del Parque, Chihuahua, Chih., Mexico

Investigational Sit, Durango, Mexico

Hospital Aranda de la Parra , S.A. de C.V., Leon, GTO, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico, Mexico, DF, Mexico

Investigational Site, Mexico, DF, Mexico

Consultorio Medico, Zapopan, Jalisco, Mexico

Investigational Site, Zapopan, Jalisco, Mexico

Investigational Site, Ede, Netherlands

Investigational Site, Eindhoven, Netherlands

Atrium MC, Heerlen, Netherlands

Hospital Andres Grillasca, Ponce, Puerto Rico

Investigational Site, Arad, Romania

Fundeni Uronephrology and Renal Transplant Clinical Institute, Bucharest, Romania

Investigational Site, Bucharest, Romania

Sfantul Ioan" Emergency Clinical Hospital, Bucharest, Romania

PROVITA 2000 Medical Center, Constanta, Romania

Investigational Site, Iasi, Romania

Sibiu Emergency Clinical County Hospital, Sibiu, Romania

City Clinical Hospital #1 n.a. N.I.Pirogov, Moscow, Russian Federation

City Clinical Hospital #60, Moscow, Russian Federation

Moscow State University of Medicine and Dentistry, Moscow, Russian Federation

City Pokrovskaya Hospital, St. Petersburg, Russian Federation

Investigational Site, St. Petersburg, Russian Federation

St.Petersburg State Medical Academy n. a. I.I.Mechnikov, St. Petersburg, Russian Federation

Dnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine

Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval, Kharkiv, Ukraine

Kyiv City Clinical Hospital #3, Kyiv, Ukraine

Odesa State Medical University, Odesa, Ukraine

Clatterbridge Centre For Oncology, Bebington, Wirral, United Kingdom

Urology Centers Of Alabama, Homewood, Alabama, United States

South Orange County Medical Research Center, Laguna Hills, California, United States

Western Clinical Research, Torrance, California, United States

Urology Associates Research, Englewood, Colorado, United States

South Florida Medical Research, Aventura, Florida, United States

Investigational Site, Ocala, Florida, United States

Regional Urology, Shreveport, Louisiana, United States

Lawrenceville Urology, Lawrenceville, New Jersey, United States

Investigational Site, Carmel, New York, United States

North Urology Research, Concord, North Carolina, United States

Investigational Site, Greensboro, North Carolina, United States

Investigational Site, Kentville, Nova Scotia, Canada

The Female/Male Health Centres, Barrie, Ontario, Canada

Brantford Urology Research, Brantford, Ontario, Canada

Burlington Professional Centre, Burlington, Ontario, Canada

The Urology Research Centre, Burlington, Ontario, Canada

Investigational Site, Newmarket, Ontario, Canada

The Female/Male Health Centres, Oakville, Ontario, Canada

State College Urologic Association, State College, Pennsylvania, United States

Urology South Shore Research, Greenfields, Quebec, Canada

Urology San Antonio Research, San Antonio, Texas, United States

Seattle Urology Research Center, Burien, Washington, United States

Additional Information

Starting date: March 2007
Last updated: March 20, 2013

Page last updated: August 23, 2015

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