Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
