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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00567879 |
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Date of registration:
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04/12/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab
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Scientific title:
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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 |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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56 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00567879 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Key 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
Key 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Trastuzumab
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Drug: Panobinostat
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Primary Outcome(s)
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Number of Participants With Dose Limiting Toxicities (DLTs)
[Time Frame: day 21]
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Secondary Outcome(s)
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Number of Participants With Best Overall Response
[Time Frame: day 21]
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Secondary ID(s)
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CLBH589C2204
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2007-002449-19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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