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Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer

NCT01084057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-11-05

No results posted yet for this study

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.

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Interventions

DRUG

vorinostat

Given orally

DRUG

ixabepilone

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Yuan Yuan, MD, PhD · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-17
Primary Completion
2012-11-12
Completion
2019-09-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084057 on ClinicalTrials.gov