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NCT05988918 · ClinicalTrials.gov registry record · Phase 2
Multicenter Trial of ESK981 in Patients With Select Solid Tumors
A Phase 2 study of Pancreatic Adenocarcinoma and Pancreatic Neuroendocrine Tumor, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 3
- Study locations
NCT05988918: Recruiting Phase 2 study of Pancreatic Adenocarcinoma and Pancreatic Neuroendocrine Tumor, sponsored by University of Michigan Rogel Cancer Center.
NCT05988918 is a Phase 2 study of Pancreatic Adenocarcinoma and Pancreatic Neuroendocrine Tumor that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 66 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05988918, a Phase 2 study of Pancreatic Adenocarcinoma and Pancreatic Neuroendocrine Tumor, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Determining efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype
Conditions Studied
Interventions
- DRUG ESK981
Study Locations (3)
Michigan
- Rogel Cancer Center - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2029-04 |
| Phase | Phase 2 |
What NCT05988918 shows while recruiting
NCT05988918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 7 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which ESK981 is the first listed.
NCT05988918 reports a single indexed study location in Michigan, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05988918 about?
NCT05988918 is a clinical study titled "Multicenter Trial of ESK981 in Patients With Select Solid Tumors". 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 enrollme...
What is the current status of trial NCT05988918?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2024-04-19. Estimated completion is 2029-04.
What conditions does trial NCT05988918 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Carcinoma, Adenosquamous Carcinoma, Gastrointestinal Neuroendocrine Tumor.
What interventions are being tested in trial NCT05988918?
The interventions under investigation include: ESK981 (DRUG).
Who is sponsoring clinical trial NCT05988918?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05988918 being conducted?
This trial has 3 study locations across Michigan, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05988918's enrollment target sits among peer trials
66 32nd of 62 higher than 31 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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