A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00567879
First received: December 4, 2007
Last updated: September 30, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: panobinostat, trastuzumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Determine the dose of oral panobinostat plus trastuzumab combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Determine the dose of iv LBH plus trastuzumab combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Explore preliminary anti-tumor activity of the combination [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Explore potential biomarkers [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: panobinostat plus trastuzumab
intravenous and oral
|
Drug: panobinostat, trastuzumab |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567879
Locations
| United States, California | |
| Novartis Investigative Site | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Novartis Investigative Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Novartis Investigative Site | |
| Norwalk, Connecticut, United States, 06856 | |
| United States, Maryland | |
| Novartis Investigative Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Missouri | |
| Novartis Investigative Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Ohio | |
| Novartis Investigative Site | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Canada, British Columbia | |
| Novartis Investigative Site | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| France | |
| Novartis Investigative Site | |
| Dijon Cedex, France, 21034 | |
| Novartis Investigative Site | |
| Paris, France, 75231 | |
| Novartis Investigative Site | |
| Saint-Herblain Cédex, France, 44805 | |
| Germany | |
| Novartis Investigative Site | |
| Heidelberg, Germany, 69115 | |
| Italy | |
| Novartis Investigative Site | |
| Meldola, FC, Italy, 47014 | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16132 | |
| Novartis Investigative Site | |
| Modena, MO, Italy, 41100 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Birmingham, United Kingdom, B15 2TH | |
| Novartis Investigative Site | |
| London, United Kingdom, W12 0NN | |
| Novartis Investigative Site | |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00567879 History of Changes |
| Other Study ID Numbers: | CLBH589C2204, 2007-002449-19 |
| Study First Received: | December 4, 2007 |
| Last Updated: | September 30, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Breast Cancer HER2 positive adult-female |
LBH589 HDAC inhibitor panobinostat |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013