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
NCT ID: NCT00567879
Last Updated: 2016-05-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2008-04-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Panobinostat with trastuzumab
Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Panobinostat
Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m\^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.
Trastuzumab
Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.
Interventions
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Panobinostat
Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m\^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.
Trastuzumab
Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of California at Los Angeles
Los Angeles, California, United States
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, United States
Norwalk Hospital Dept of Norwalk Hospital (2)
Norwalk, Connecticut, United States
VA Maryland Health Care Dept.of GreenbaumCancerCent(3)
Baltimore, Maryland, United States
The Center for Cancer Care and Research
St Louis, Missouri, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC
Columbus, Ohio, United States
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Kelowna, British Columbia, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Dijon, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Saint-Herblain Cédex, , France
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2007-002449-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589C2204
Identifier Type: -
Identifier Source: org_study_id
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