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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90Y-hPAM4 | Experimental | 90Y-hPAM4 is administered weekly for 3 weeks |
|
| 90Y-hPAM4 + gemcitabine | Experimental | 90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90Y-hPAM4 | Drug | 90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage determination | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William A Wegener, MD, PhD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Healthcare | Gilbert | Arizona | 85234 | United States | ||
| Scottsdale Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26187510 | Derived | 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. |
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|
| 90Y-hPAM4 | Drug |
|
|
| 90Y-hPAM4 + gemcitabine | Drug |
|
|
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 |
| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000589320 | clivatuzumab |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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