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 (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00493766
First received: June 26, 2007
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: LBH589
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • • 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 ]

Secondary Outcome Measures:
  • • 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 ]

Enrollment: 16
Study Start Date: May 2006
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral LBH589 alone Drug: LBH589
Experimental: oral LBH589 + IV docetaxel + oral prednisone Drug: LBH589

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493766

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6-84
United States, Missouri
Washing University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00493766     History of Changes
Other Study ID Numbers: CLBH589B2105
Study First Received: June 26, 2007
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
LBH589
Prostate Cancer
HRPC
Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014