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RECRUITING
NCT05988918
PHASE2

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

Official title: A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-04-19

Completion Date

2029-04

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

ESK981

160 mg, PO, Once daily 5 days on and 2 days off

Locations (3)

Rogel Cancer Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States