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Keep this study
Lead
University of Oklahoma
With
Celgene Corporation
This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
Karnofsky performance status of greater than or equal to 70%
Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
Women of child bearing age must have negative serum pregnancy test prior to treatment
You may not be if
Known central nervous system tumor involvement
Evidence of other active malignancy requiring treatment
Clinically significant heart disease
Active serious systemic disease, including active bacterial or fungal infection
Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
Prior surgery with curative intent for pancreatic cancer
Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
Breast feeding, pregnant, or likely to become pregnant during the study
known or suspected hypersensitivity to azacitidine or mannitol
Clareo Health | Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
