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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT01510561
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, ≥ 18 years of age, who are able to understand and give written informed consent
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections
* Previously treated and received two prior treatment regimens for advanced disease
* Karnofsky performance status ≥ 60 % (Appendix A)
* Expected survival ≥ 3 months
* At least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy, other experimental treatments
* At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
* Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, ANC \> 1,500 per mm3, platelets \> 100,000 per mm3)
* Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN \[5.0 X IULN if due to liver metastases\])
* Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to baseline or discussed with and agreed to with Immunomedics' Medical Monitor.
Exclusion Criteria:
* Women who are pregnant or lactating
* Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period
* Known metastatic disease to the central nervous system
* Presence of bulky disease (defined as any single mass \> 10 cm in its greatest dimension)
* Patients with \> Grade 2 nausea or vomiting and/or signs of intestinal obstruction
* Prior radiation dose \> 3,000 cGy to the liver, \> 2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow
* Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval
* Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
* Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months, or cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
* Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months
* Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids)
* Infection requiring intravenous antibiotic use within 1 week
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01510561
Study Brief:
Protocol Section:
NCT01510561