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

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

Objective
Primary Objective: Determine efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype

Secondary Objectives:
1) Determine overall response rate (ORR), duration of response (DoR), median progression-free survival (PFS) and overall survival (OS) within each cancer subtype
2) Determine safety and tolerability in each cancer subtype

Exploratory Objective: To collect tissue and serial blood for exploratory biomarker analysis including genomics, transcriptomic, proteomics and autophagic flux via metabolomics.

Treatment 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.

Key Eligibility For full eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Gastrointestinal cancers, other; Pancreas; Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital