Trials / Recruiting
RecruitingNCT05988918
Multicenter Trial of ESK981 in Patients With Select Solid Tumors
A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Pancreatic Adenocarcinoma
- Adenosquamous Carcinoma
- Pancreatic Neuroendocrine Tumor
- Pancreatic Neuroendocrine Carcinoma
- Gastrointestinal Neuroendocrine Tumor
- Gastrointestinal Neuroendocrine Carcinoma
- Neuroendocrine Prostate Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ESK981 | 160 mg, PO, Once daily 5 days on and 2 days off |
Timeline
- Start date
- 2024-04-19
- Primary completion
- 2027-04-01
- Completion
- 2029-04-01
- First posted
- 2023-08-14
- Last updated
- 2026-03-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05988918. Inclusion in this directory is not an endorsement.