Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT00419536

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 3 Locations for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Washington University School of Medicine
St. Louis Missouri, 63119, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT00419536

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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