Study Stopped
no subjects enrolled
A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
A Ph Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.
1 other identifier
interventional
N/A
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 19, 2021
December 1, 2020
3.3 years
January 5, 2012
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (change in hematology and chemistry laboratory values from baseline)
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 Outcomes (2)
Dosage determination
2 years
Efficacy
1 year
Study Arms (2)
90Y-hPAM4
EXPERIMENTAL90Y-hPAM4 is administered weekly for 3 weeks
90Y-hPAM4 + gemcitabine
EXPERIMENTAL90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
Interventions
90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (24)
Banner Healthcare
Gilbert, Arizona, 85234, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Christiana Care Health Services Helen Graham Cancer Center
Newark, Delaware, 19713, United States
Sylvester Comprehensive Cancer Center Univ. Miami
Miami, Florida, 33136, United States
Jackson North Medical Center
Miami, Florida, 33169, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30308, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Detroit Clinical Research Center
Detroit, Michigan, 48377, United States
St. Mary's Trinity Healthcare
Grand Rapids, Michigan, 49503, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131, United States
Weill Cornell NY Presbyterian Hospital
New York, New York, 10021, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Kimmel Cancer Center at Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Institute of Translational Oncology Research
Greenville, South Carolina, 29605, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
VA Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Related Publications (1)
Picozzi VJ, Ramanathan RK, Lowery MA, Ocean AJ, Mitchel EP, O'Neil BH, Guarino MJ, Conkling PR, Cohen SJ, Bahary N, Frank RC, Dragovich T, Bridges BB, Braiteh FS, Starodub AN, Lee FC, Gribbin TE, Richards DA, Lee M, Korn RL, Pandit-Taskar N, Goldsmith SJ, Intenzo CM, Sheikh A, Manzone TC, Horne H, Sharkey RM, Wegener WA, O'Reilly EM, Goldenberg DM, Von Hoff DD. (90)Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies. Eur J Cancer. 2015 Sep;51(14):1857-64. doi: 10.1016/j.ejca.2015.06.119. Epub 2015 Jul 14.
PMID: 26187510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William A Wegener, MD, PhD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 16, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
August 19, 2021
Record last verified: 2020-12