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

NCT05988918 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	17
Start date	2024-04-19
Completion	2027-08

Conditions

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

Interventions

• ESK981

Primary outcomes

• Progression Free Survival — 4 months after initiating study drug
  Determining efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype

Countries

United States