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Brief Title: Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
Official Title: A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
Study ID: NCT00493766
Brief Summary: This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washing University School of Medicine, Saint Louis, Missouri, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR