Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
Stopped early · Phase 1
Conditions studied: Hormone Refractory Prostate Cancer
In brief
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
Key facts
- Study ID
- NCT00493766
- Run by
- Novartis Pharmaceuticals
- People needed
- 16
- Starts
- 2006-05-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically documented adenocarcinoma of the prostate.
- Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry.
- Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment
- Patients must be able to provide written informed consent
You may not qualify if…
- Patients with prior or concurrent brain metastases
- Impaired cardiac, gastrointestinal, kidney, or liver function
- Use of therapeutic androgens
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Washing University School of Medicine — St 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
Full record on ClinicalTrials.gov
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