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

Phase 1
18 Years
Open (Enrolling)
Metastatic Pancreatic Adenocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer

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Trial Information

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

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

- 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

- Known metastatic disease to the central nervous system

- Presence of bulky disease (defined as any single mass > 10 cm in its greatest

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (change in hematology and chemistry laboratory values from baseline)

Outcome Description:

Acute safety will be assessed weekly for the 1st 12 weeks, and then for up to 1 year after completion of study drug treatment. Safety will be assessed by comparing baseline hematology and chemistry laboratory values with the values obtained weekly after treatment. Safety will also be assessed by the adverse events that are reported.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

William A Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • metastatic pancreatic adenocarcinoma
  • pancreatic cancer
  • metastatic pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



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