Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Utah
With
Celgene Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
3. Her-2/neu negative (Phase II)
4. Negative pregnancy test for female subjects
5. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
6. Male or female for phase I and female for phase II, \>19 years of age and any race.
You may not be if
1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
2. Known brain metastases
3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
4. Active infection requiring antibiotic therapy
5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
6. Grade 2 or greater motor or sensory neuropathy
7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
9. Known or suspected hypersensitivity to azacitidine or mannitol
10. Pregnant or breast feeding
11. Patients with advanced malignant hepatic tumors
12. Malignancy other than breast carcinoma (phase II)
13. Known HIV infection or chronic hepatitis B or C
