Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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