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Multicenter Trial of ESK981 in Patients With Select Solid Tumors

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment reduced: 66 → 17 participantsv10 Show 4 more changesShow less
    • Primary completion moved earlier from Apr 2027 to Feb 21, 2026
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Study completion moved earlier from Apr 2029 to Aug 2027
    • Study sites: 3 to 2
  2. Site details revised at 2 of 3 sitesv9
  3. Re-verified, no change to tracked fieldsv8
  4. Eligibility criteria revisedv7
  5. Study sites: 1 to 3v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: May 2027 to Apr 2027
    • Study completion date: May 2029 to Apr 2029
    • Start date changed from estimate of May 2024 to Apr 19, 2024
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  3. Start date: Jan 2024 to May 2024
    • Primary completion date: Jan 2027 to May 2027
    • Study completion date: Jan 2029 to May 2029
    v3
  4. Start date: Oct 2023 to Jan 2024
    • Primary completion date: Aug 2026 to Jan 2027
    • Study completion date: Sep 2028 to Jan 2029
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05988918
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Pancreatic Adenocarcinoma, Adenosquamous Carcinoma, Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Carcinoma, Gastrointestinal Neuroendocrine Tumor, Gastrointestinal Neuroendocrine Carcinoma, Neuroendocrine Prostate Carcinoma
Related terms Adenoma, Islet Cell, Carcinoma, Adenosquamous, Gastro-enteropancreatic neuroendocrine tumor, Somatostatinoma
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov