Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

Novartis

Status and phase: Terminated; Phase 1

Conditions: Hormone Refractory Prostate Cancer Disease

Treatments: Drug: LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419536

CLBH589A2105

Details and patient eligibility

About

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hormone refractory prostate cancer
• Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
• Patients must meet laboratory inclusion criteria defined in the protocol
• 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: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)