Condition: Metastatic Pancreatic Ductal Adenocarcinoma · PDAC · Sponsor: AbbVie
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide. Phase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage,…
This description comes directly from the study's public registry record.
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| University of Chicago Medical Center /ID# 279460 | Chicago, Illinois, United States | Recruiting |
| City Of Hope - Chicago /ID# 279814 | Zion, Illinois, United States | Recruiting |
| Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853 | Grand Rapids, Michigan, United States | Recruiting |
| Texas Oncology - Northeast Texas /ID# 280417 | Tyler, Texas, United States | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 280415 | Fairfax, Virginia, United States | Recruiting |
| Tamworth Hospital /ID# 280099 | North Tamworth, New South Wales, Australia | Not Yet Recruiting |
| Prince Of Wales Hospital - Randwick /ID# 280085 | Randwick, New South Wales, Australia | Not Yet Recruiting |
| Monash Health - Monash Medical Centre - Clayton /ID# 280076 | Clayton, Victoria, Australia | Not Yet Recruiting |
| Austin Hospital /ID# 280283 | Melbourne, Victoria, Australia | Recruiting |
| Fiona Stanley Hospital /ID# 280079 | Murdoch, Western Australia, Australia | Not Yet Recruiting |
| The Chaim Sheba Medical Center /ID# 279408 | Ramat Gan, Tel Aviv, Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 279414 | Tel Aviv, Tel Aviv, Israel | Recruiting |
+ 9 more locations — full list on the registry record.
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