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

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00788931

Purpose

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

Condition	Intervention	Phase
HER2 Positive Metastatic Breast Cancer	Drug: panobinostat in combination with trastuzumab and paclitaxel	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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)

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	52
Study Start Date:	December 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental i.v. panobinostat	Drug: panobinostat in combination with trastuzumab and paclitaxel
2: Experimental oral panobinostat	Drug: panobinostat in combination with trastuzumab and paclitaxel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788931

Contacts

Contact: Novartis Pharmaceuticals

+1 800 330 6843

Locations

Australia
Novartis Investigative Site
Woodville, Australia
Belgium
Novartis Investigative Site
Liege, Belgium
Novartis Investigative Site
Bruxelles, Belgium
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Novartis Investigative Site
St. Petersburg, Russian Federation
Sweden
Novartis Investigative Site
Uppsala, Sweden

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLBH589C2114, EudraCT 2007-004788-23
Study First Received:	October 24, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00788931
Health Authority:	United States: Food and Drug Administration; Australia: National Health and Medical Research Council; Belgium: Federal Agency for Medicinal Products and Health Products; Italy: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Russia: Ministry of Health and Social Development of the Russian Federation; Sweden: The National Board of Health and Welfare

Keywords provided by Novartis:

Breast Cancer
HER2 positive
adult-female
LBH589

HDAC inhibitor
panobinostat
HER2 positive metastatic breast cancer in adult female patients

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009