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A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer

NCT00748553 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-07-26

Study results available
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Summary

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Conditions

  • Advanced or Metastatic Solid Tumors
  • Advanced or Metastatic Breast Cancer

Interventions

DRUG

Azacitidine (Vidaza)

50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle

DRUG

Nab-paclitaxel (Abraxane)

100mg/m2 weekly for 3 weeks of each 4-week cycle

Sponsors & Collaborators

Principal Investigators

  • Hung T Khong, MD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00748553 on ClinicalTrials.gov