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

Tracking Information

First Received Date ^ICMJE

October 24, 2008

Last Updated Date

November 17, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: At least 21 day cycle for both arms ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00788931 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. [ Time Frame: throughout the study and 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

HER2 Positive
Metastatic Breast Cancer

Intervention ^ICMJE

Drug: panobinostat in combination with trastuzumab and paclitaxel

Study Arms / Comparison Groups

Experimental: i.v. panobinostat
Experimental: oral panobinostat

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

July 2010 (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 organ functions
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

Patients who have had surgery within last 2 weeeks prior to starting the treatment
Patients who receive concurent 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+1 800 330 6843

Location Countries ^ICMJE

Australia, Belgium, Netherlands, Russian Federation, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00788931

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CLBH589C2114, EudraCT 2007-004788-23

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2009

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