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:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT02436668
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
2. Stage IV disease diagnosed within 6 weeks of randomization
3. Adequate hematologic function:
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* Hemoglobin ≥9 g/dL
4. Adequate hepatic and renal function defined as:
* AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
* Alkaline phosphatase \<3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
* Estimated Creatinine Clearance ≥30 mL/min
5. PT/INR \<1.5 x ULN and PTT (aPTT) \<1.5 x ULN
6. KPS ≥70.
7. Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
4. Major surgery within 4 weeks of first dose of study drug.
5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02436668
Study Brief:
Protocol Section:
NCT02436668