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

NCT00493766 | Terminated Phase 1

• 1 other identifier: CLBH589B2105
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

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

Conditions

Hormone Refractory Prostate Cancer

Keywords

LBH589; Prostate Cancer; HRPC; Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• • 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

• • 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 Outcomes (2)

• • 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

• • 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

Study Arms (2)

oral LBH589 alone

EXPERIMENTAL

Drug: LBH589

oral LBH589 + IV docetaxel + oral prednisone

EXPERIMENTAL

Drug: LBH589

Interventions

LBH589 DRUG

oral LBH589 + IV docetaxel + oral prednisone; oral LBH589 alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with prior or concurrent brain metastases
• Impaired cardiac, gastrointestinal, kidney, or liver function
• Use of therapeutic androgens

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115-6-84, United States

Location

Washing University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Last Updated: December 19, 2020

Record last verified: 2012-11

Locations

US (5)