RecruitingPhase 2NCT05988918

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

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

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

66 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Adenocarcinoma Pancreatic Neuroendocrine Tumor Gastrointestinal Neuroendocrine Tumor Adenosquamous Carcinoma Pancreatic Neuroendocrine Carcinoma Gastrointestinal Neuroendocrine Carcinoma Neuroendocrine Prostate Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called ESK981 in people with specific advanced cancers — including pancreatic cancer, prostate cancer, bladder cancer, and kidney cancer — to see if it is safe and whether it slows cancer growth. **You may be eligible if...** - You have a confirmed diagnosis of advanced cancer in one of the following groups: pancreatic, prostate, bladder (urothelial), or kidney (clear cell) cancer - You have already received standard chemotherapy or other treatments and your cancer has progressed **You may NOT be eligible if...** - Your cancer type is not one of the specific types in the study - You have not yet tried standard treatment options - Your general health prevents safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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