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

This study has been terminated.

(Because of a strategic decision by Novartis)

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00493766

First received: June 26, 2007

Last updated: August 31, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 26, 2007

Last Updated Date

August 31, 2010

Start Date ^ICMJE

May 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC. [ Time Frame: at study start and at study end ] [ Designated as safety issue: No ]
• 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. [ Time Frame: at study start and at study end ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Maximum tolerated dose

Change History

Complete list of historical versions of study NCT00493766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities [ Time Frame: at study start and at study end ] [ Designated as safety issue: No ]
• 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. [ Time Frame: at study start and at study end ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety Pharmacokinetic profile Preliminary antitumor activity

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hormone Refractory Prostate Cancer

Intervention ^ICMJE

Drug: LBH589

Study Arm (s)

Experimental: oral LBH589 alone
Intervention: Drug: LBH589
Experimental: oral LBH589 + IV docetaxel + oral prednisone
Intervention: Drug: LBH589

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00493766

Other Study ID Numbers ^ICMJE

CLBH589B2105

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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