A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
The phase I part of the study will enroll patients with advanced or metastatic solid tumors
who have failed at least one previous treatment. The purpose of the phase I part is to
assess the safety of the investigational treatment and select the recommended phase II
dose-regimen. The phase II part of the study will enroll patients with advanced or
metastatic HER2-negative breast cancer who have not received treatment for their metastatic
disease. The purpose of the phase II part of the study is to assess safety and efficacy of
the investigational treatment in breast cancer. The study doctor will determine what phase
patients will be enrolled in.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To assess safety of Vidaza and Abraxane combination and to select the recommended phase II dose-regimen
6 months
Yes
Hung T Khong, MD
Principal Investigator
University of Utah
United States: Institutional Review Board
HCI53993
NCT00748553
September 2008
November 2013
Name | Location |
---|---|
University of Utah Huntsman Cancer Institute | Salt Lake City, Utah 84112 |