Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02030067
Eligibility Criteria:
Inclusion Criteria:
* Males or females who are 18 years or older
* Able to swallow capsules
* Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer
* Able to discontinue all anticancer therapies 2 weeks prior to study start
* Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors
* Life expectancy of at least 3 months
* ECOG performance status of 0 or 1
* Provide written informed consent
Exclusion Criteria:
* Primary brain tumors or clinical evidence of active brain metastasis
* Systemic corticosteroid use within 7 days before planned start of study therapy
* Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy
* Uncontrolled diabetes as assessed by the investigator
* Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus
* History of bone marrow of solid organ transplantation
* History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes
* Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
* Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside
* Pregnant, planning a pregnancy or breast feeding during the study
* Concurrent participation in another therapeutic clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02030067
Study Brief:
Protocol Section:
NCT02030067