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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510561
Recruitment Status : Unknown
Verified February 2015 by Immunomedics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2012
Last Update Posted : February 16, 2015
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Pancreatic Cancer Metastatic Pancreatic Cancer Drug: 90Y-hPAM4 Drug: 90Y-hPAM4 + gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
Study Start Date : March 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 90Y-hPAM4
90Y-hPAM4 is administered weekly for 3 weeks
Drug: 90Y-hPAM4
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
Other Name: Clivatuzumab Tetraxetan
Drug: 90Y-hPAM4
Other Name: clivatuzumab tetraxetan
Experimental: 90Y-hPAM4 + gemcitabine
90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
Drug: 90Y-hPAM4
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
Other Name: Clivatuzumab Tetraxetan
Drug: 90Y-hPAM4
Other Name: clivatuzumab tetraxetan
Drug: 90Y-hPAM4 + gemcitabine
Other Names:
  • gemzar
  • clivatuzumab tetraxetan

Primary Outcome Measures :
  1. Safety (change in hematology and chemistry laboratory values from baseline) [ Time Frame: 1 year ]
    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.

Secondary Outcome Measures :
  1. Dosage determination [ Time Frame: 2 years ]
    This study is also being done to determine an acceptable 90Y-hPAM4 dose in this patient population. It is anticipated that enrollment will occur over 2 years.

  2. Efficacy [ Time Frame: 1 year ]
    Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01510561

  Hide Study Locations
United States, Arizona
Banner Healthcare
Gilbert, Arizona, United States, 85234
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Delaware
Christiana Care Health Services Helen Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Florida
Sylvester Comprehensive Cancer Center Univ. Miami
Miami, Florida, United States, 33136
Jackson North Medical Center
Miami, Florida, United States, 33169
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30308
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Indiana
Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Michigan
Detroit Clinical Research Center
Detroit, Michigan, United States, 48377
St. Mary's Trinity Healthcare
Grand Rapids, Michigan, United States, 49503
United States, New Mexico
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87131
United States, New York
Weill Cornell NY Presbyterian Hospital
New York, New York, United States, 10021
Mt. Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Kimmel Cancer Center at Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Institute of Translational Oncology Research
Greenville, South Carolina, United States, 29605
United States, Texas
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
VA Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William A Wegener, MD, PhD Immunomedics, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Immunomedics, Inc. Identifier: NCT01510561     History of Changes
Other Study ID Numbers: IM-T-hPAM4-03
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Immunomedics, Inc.:
metastatic pancreatic adenocarcinoma
pancreatic cancer
metastatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies, Monoclonal
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents