GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers
NCT01118975 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2019-11-13
Summary
This research is being done to find out how safe and how well the combination of lapatinib and vorinostat works against advanced cancers.
Conditions
- Breast Cancer
- Neoplasm Metastasis
Interventions
- DRUG
-
Vorinostat
300 mg 4 days on then 3 days off As defined in the protocol, the dose of vorinostat was increased to 400 mg 4 days on then 3 days off in the pilot phase because the adverse event threshold was not met. In the Phase II cohort, the dose of vorinistat was 400 mg 4 days on and 3 days off.
- DRUG
-
Lapatinib
1,250 mg once daily
Sponsors & Collaborators
-
University of Maryland Greenebaum Cancer Center
collaborator OTHER -
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Saranya Chumsri, MD · University of Maryland, College Park
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-31
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- United States
Study Locations
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