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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 4, 2007

Last Updated Date

January 28, 2009

Start Date ^†

December 2007

Current Primary Outcome Measures ^†

Determine the dose of oral panobinostat plus trastuzumab combination Determine the dose of iv LBH plus trastuzumab combination Explore preliminary anti-tumor activity of the combination

Original Primary Outcome Measures ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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 ^†

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

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Breast Cancer

Intervention ^†

Drug: LBH589/panobinostat

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

118

Completion Date

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis	862 778 8300
Contact: Novartis Basel	41 61 324 1111

Location Countries ^†

United States, Canada, France, Germany, Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00567879

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Information Provided By

Novartis

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.