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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

December 4, 2007
September 30, 2012
April 2008
May 2011   (final data collection date for primary outcome measure)
  • 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 ]
Determine the dose of oral LBH plus trastuzumab combination Determine the dose of iv LBH plus trastuzumab combination Explore preliminary anti-tumor activity of the combination
Complete list of historical versions of study NCT00567879 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy throughout the study Safety and tolerability throughout the study Explore potential biomarkers
Not Provided
Not Provided
 
A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: panobinostat, trastuzumab
Experimental: panobinostat plus trastuzumab
intravenous and oral
Intervention: Drug: panobinostat, trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Italy,   United Kingdom
 
NCT00567879
CLBH589C2204, 2007-002449-19
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2012

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