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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00663832 |
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: LBH589 (i.v. panobinostat) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 46 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
LBH589: Experimental |
Drug: LBH589 (i.v. panobinostat)
i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis Pharmaceuticals | +1-800-340-6843 |
United States, Michigan | |
Wayne State University/Karmanos Cancer Center | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Brenda Dickow 313-576-8715 dickowb@karmamos.org | |
Principal Investigator: Ulka Vaishampayan, M.D. | |
United States, Missouri | |
Washington University School of Medicine in St. Louis | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Jessica Weinstein 314-747-8085 jweinstei@im.wustl.edu | |
Principal Investigator: Joel Picus, M.D. | |
United States, Nevada | |
Nevada Cancer Institute | Recruiting |
Las Vegas, Nevada, United States, 89135 | |
Contact: Sandra Lehr 702-822-5433 slahr@nvcancer.org | |
Principal Investigator: Bryan Wong, M.D. | |
United States, New York | |
Memorial Sloane Kettering Cancer Center | Recruiting |
New York, New York, United States, 10017 | |
Contact: Erika Tanaka 646-422-4330 tanakae@mskcc.org | |
Principal Investigator: Dana Rothkopf, M.D | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Danny DeHaze 503-418-9392 dehazed@ohsu.edu | |
Contact: Justina Barberini barberin@ohsu.edu | |
Principal Investigator: Joshi Alumkal, M.D. | |
Canada | |
Novartis Investigative Site | Recruiting |
Ontario, Canada | |
Canada, British Columbia | |
Novartis Investigative Site | Recruiting |
Vancouver, British Columbia, Canada |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLBH589C2205, EUDRACT # = 2007-003315-30 |
Study First Received: | April 18, 2008 |
Last Updated: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00663832 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Male Prostate Cancer HRPC DACi |
Anti-Inflammatory Agents Prednisone Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Glucocorticoids Docetaxel Signs and Symptoms Prostatic Neoplasms |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |