A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788931
• Other study ID #: CLBH589C2114
• Secondary ID: 2007-004788-23
• Status: Completed
• Phase: Phase 1
• Start date: December 2008

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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 when given in combination with trastuzumab and paclitaxel. 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: 15
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 year old

• Confirmed HER2+ metastatic breast cancer

• Prior treatment and progression on trastuzumab

• Patients must have adequate organ functions

• Eastern Cooperative Oncology Group (ECOG) performance status of = 1

Exclusion Criteria:

• Patients who have had surgery within last 2 weeks prior to starting the treatment

• Patients who receive concurrent therapy for brain metastases

• Impaired heart function or clinically significant heart disease

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER-2 Positive Breast Cancer
• Metastatic Breast Cancer

Intervention

Drug:
• IV LBH589

• Oral LBH589

• trastuzumab

• paclitaxel

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Woodville	South Australia
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Liege
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Macerata	MC
Netherlands	Novartis Investigative Site	Amsterdam
United States	Novartis Investigative Site	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.		At least 21 day cycle for both arms
Secondary	Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.		4 weeks after end of treatment
Secondary	To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.		throughout the study and 4 weeks after end of treatment

External Links

•   Results for LBH589C2114 can be found on the Novartis Clinical Trial Results Website