A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors
University of Michigan Rogel Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria: * Patients with histological or cytological confirmation of advanced cancer per specific cohort. * Cohort 1: Pancreatic adenocarcinoma or adenosquamous carcinoma who have progressed or deemed intolerant of the standard of care chemotherapy regimens. * Cohort 2: Pancreatic or gastrointestinal neuroendocrine tumor or carcinoma with Ki-67 \> 20% who have progressed or deemed intolerant of at least first-line standard of care systemic therapy. * Cohort 3: The subject has histologically proven prostate cancer who have progressed or deemed intolerant of at least first-l…
Interventions
- DrugESK981
160 mg, PO, Once daily 5 days on and 2 days off
Locations (3)
- Rogel Cancer CenterAnn Arbor, Michigan
- Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
- University of Wisconsin Carbone Cancer CenterMadison, Wisconsin