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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01558869
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years of age, male or female.
* Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
* ECOG performance status 0 to 2.
* Adequate bone marrow reserve.
* Absolute neutrophil count \> 1x10\^9/L.
* Total bilirubin \<3 times the upper limit of the normal range.
* Life expectancy ≥ 12 weeks.
* Signed written informed consent form.
Exclusion Criteria:
* Prior malignant disease other than pancreatic cancer.
* Patients suitable for surgical or locoregional therapies.
* Patients who have prior anticancer therapy for pancreatic cancer.
* Patients unable to swallow oral medications.
* Any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
* Active clinically serious infections (\> grade 2 NCI / CTC Adverse Event version 3.0).
* History of allergy to platinum compounds.
* Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
* Patients who have severe bone marrow failure.
* Patients undergoing renal dialysis.
* History of HIV infection.
* Seizure disorder requiring medication (such as steroids or anti-epileptics).
* Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01558869
Study Brief:
Protocol Section:
NCT01558869