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Azacitidine and Nab-paclitaxel in Advanced Solid Tumors and Breast Cancer
NCT00748553Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2008
- Primary completion
- Oct 2015
- Countries
- 1
- Sponsor
- University of Utah
- Modality
- Small Molecules
- Drugs
- azacitidine
- Conditions
- solid tumorbreast cancer
01
Overview
Phase 2, open-label, single-arm trial of azacitidine in solid tumor and breast cancer, sponsored by University of Utah. Primary endpoints: Percentage of Participants Responding to Treatment at 6 months and Objective Response Rate at 1.5 years. Started Sep 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
All patients
Azacitidine + Nab-paclitaxel
03
Who it enrols
Patients with advanced solid tumors (Phase I) or HER2-negative metastatic breast cancer (Phase II). Phase I requires progression on at least one prior therapy. Phase II requires no prior treatment for metastatic disease.
04
Endpoints
Primary
Percentage of Participants Responding to Treatment
Objective Response Rate
Secondary
Number of Participants With ER+ Status
Progression-free Survival
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