Spots Global Cancer Trial Database for Multicenter Trial of ESK981 in Patients With Select Solid Tumors
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Trial Identification
Brief Title: Multicenter Trial of ESK981 in Patients With Select Solid Tumors
Official Title: A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors
Study ID: NCT05988918
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rogel Cancer Center, Ann Arbor, Michigan, United States
Contact Details
Name: Vaibhav Sahai
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR
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