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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00419536
First received: January 5, 2007
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group 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

Secondary Outcome Measures:
  • Safety
  • Tolerability
  • Biologic activity
  • Pharmacokinetic profile

Estimated Enrollment: 108
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419536

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63119
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00419536     History of Changes
Other Study ID Numbers: CLBH589A2105
Study First Received: January 5, 2007
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
LBH
LBH589
Prostate Cancer
HRPC

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 July 29, 2014