Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Condition
Pancreatic Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Rogel Cancer Center, Ann Arbor, Michigan, United States, 48109

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Madison

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    University of Michigan Rogel Cancer Center,

    Vaibhav Sahai, PRINCIPAL_INVESTIGATOR, University of Michigan

    Study Record Dates

    2029-04