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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567879
• Other study ID #: CLBH589C2204
• Secondary ID: 2007-002449-19
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2007
• Last updated: January 21, 2016
• Start date: April 2008
• Est. completion date: May 2011

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• panobinostat, trastuzumab

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Kelowna	British Columbia
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Dijon Cedex
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Saint-Herblain Cédex
Germany	Novartis Investigative Site	Heidelberg
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Meldola	FC
Italy	Novartis Investigative Site	Modena	MO
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Norwalk	Connecticut
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the dose of oral panobinostat plus trastuzumab combination		throughout the study	No
Primary	Determine the dose of iv LBH plus trastuzumab combination		throughout the study	No
Primary	Explore preliminary anti-tumor activity of the combination		throughout the study	No
Secondary	Efficacy		throughout the study	No
Secondary	Safety and tolerability		throughout the study	Yes
Secondary	Explore potential biomarkers		throughout the study	No

External Links

•   Breast Cancer