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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2007

Last Updated Date

September 30, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00567879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy throughout the study Safety and tolerability throughout the study Explore potential biomarkers

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: panobinostat, trastuzumab

Study Arm (s)

Experimental: panobinostat plus trastuzumab

intravenous and oral

Intervention: Drug: panobinostat, trastuzumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, France, Germany, Italy, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00567879

Other Study ID Numbers ^ICMJE

CLBH589C2204, 2007-002449-19

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

September 2012

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

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