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Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00788931 |
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 |
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) |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis Pharmaceuticals | +1 800 330 6843 |
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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 |
Breast Cancer HER2 positive adult-female LBH589 |
HDAC inhibitor panobinostat HER2 positive metastatic breast cancer in adult female patients |
Skin Diseases Paclitaxel Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |