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

Hormone Refractory Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493766
• Other study ID #: CLBH589B2105
• Status: Terminated
• Phase: Phase 1
• Start date: May 2006

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• LBH589

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Washing University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.		at study start and at study end
Primary	• To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC.		at study start and at study end
Secondary	• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities		at study start and at study end
Secondary	• To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589.		at study start and at study end

External Links

•   Results for CLBH589B2105 can be found on the Novartis Clinical Trial Results Website