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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 26, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT01084057). This is a study registration, not published results. Lead sponsor: City of Hope Medical Center. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 56 participants (ACTUAL). Conditions: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer. Interventions: DRUG: vorinostat; DRUG: ixabepilone; OTHER: laboratory biomarker analysis; OTHER: pharmacological study. Primary outcome measures: Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity , Cohort A evaluated every 3 weeks during treatment, Cohort B every 4 weeks during treatment.. Brief summary: RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body.