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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01510561
First received: January 5, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer
Metastatic Pancreatic Cancer
Drug: 90Y-hPAM4
Drug: 90Y-hPAM4 + gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • Safety (change in hematology and chemistry laboratory values from baseline) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Dosage determination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510561

  Show 24 Study Locations
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William A Wegener, MD, PhD Immunomedics, Inc.
  More Information

No publications provided

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01510561     History of Changes
Other Study ID Numbers: IM-T-hPAM4-03
Study First Received: January 5, 2012
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014