Clinical Trial

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Active, Not Recruiting Phase 2
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Summary
This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-15
notable Enrollment reduced: 66 -> 17 participants 2026-05-15
notable Primary completion moved earlier: 2027-04 -> 2026-02-21 2026-05-15
minor Completion moved earlier: 2029-04 -> 2027-08 2026-05-15
Trial Details
NCT Number NCT05988918
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions Pancreatic Adenocarcinoma, Adenosquamous Carcinoma, Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Carcinoma, Gastrointestinal Neuroendocrine Tumor, Gastrointestinal Neuroendocrine Carcinoma, Neuroendocrine Prostate Carcinoma
Enrollment 17 participants
Start Date 2024-04-19
Primary Completion 2026-02-21 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-14