A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.

Gilead Sciences

Status and phase: Withdrawn; Phase 1

Conditions: Metastatic Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer; Pancreatic Cancer

Treatments: Drug: 90Y-hPAM4; Drug: 90Y-hPAM4 + gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510561

IM-T-hPAM4-03

Details and patient eligibility

About

90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

90Y-hPAM4

Experimental group

Description:

90Y-hPAM4 is administered weekly for 3 weeks

Treatment:

Drug: 90Y-hPAM4

Drug: 90Y-hPAM4

90Y-hPAM4 + gemcitabine

Experimental group

Description:

90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.

Treatment:

Drug: 90Y-hPAM4

Drug: 90Y-hPAM4 + gemcitabine

Drug: 90Y-hPAM4