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

August 12, 2021 updated by: Gilead Sciences

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Clivatuzumab Tetraxetan
Drug: 90Y-hPAM4
Other Names:
  • 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 Names:
  • Clivatuzumab Tetraxetan
Drug: 90Y-hPAM4
Other Names:
  • clivatuzumab tetraxetan
Drug: 90Y-hPAM4 + gemcitabine
Other Names:
  • gemzar
  • clivatuzumab tetraxetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (ESTIMATE)

January 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hPAM4-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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