A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00567879
First received: December 4, 2007
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer


Condition Intervention Phase
Breast Cancer
Drug: panobinostat, trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determine the dose of oral panobinostat plus trastuzumab combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Determine the dose of iv LBH plus trastuzumab combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Explore preliminary anti-tumor activity of the combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Explore potential biomarkers [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: April 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: panobinostat plus trastuzumab
intravenous and oral
Drug: panobinostat, trastuzumab

  Eligibility

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

Inclusion criteria:

  • Age > 18 year old
  • Confirmed HER2+ ve metastatic breast cancer
  • Prior treatment and progression on trastuzumab
  • Patients must have adequate laboratory values
  • Eastern Cooperative Oncology Group (ECOG) performance status of <2

Exclusion criteria:

  • Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
  • Impaired heart function or clinically significant heart disease
  • Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
  • Ongoing diarrhea
  • Liver or renal disease with impaired hepatic or renal functions
  • Concomitant use of any anti-cancer therapy or certain drugs
  • Female patients who are pregnant or breast feeding
  • Patients not willing to use an effective method of birth control
  • 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: NCT00567879

Locations
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90095
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Novartis Investigative Site
Norwalk, Connecticut, United States, 06856
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21201
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63141
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15232
Canada, British Columbia
Novartis Investigative Site
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
France
Novartis Investigative Site
Dijon Cedex, France, 21034
Novartis Investigative Site
Paris, France, 75231
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Germany
Novartis Investigative Site
Heidelberg, Germany, 69115
Italy
Novartis Investigative Site
Meldola, FC, Italy, 47014
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Modena, MO, Italy, 41100
United Kingdom
Novartis Investigative Site
Birmingham, United Kingdom, B15 2TH
Novartis Investigative Site
London, United Kingdom, W12 0NN
Novartis Investigative Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00567879     History of Changes
Other Study ID Numbers: CLBH589C2204, 2007-002449-19
Study First Received: December 4, 2007
Last Updated: September 30, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Breast Cancer
HER2 positive
adult-female
LBH589
HDAC inhibitor
panobinostat

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014