RECRUITING

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-19
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05988918

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cancer AnswerLine
CONTACT
1-800-865-1125
CancerAnswerLine@med.umich.edu

Principal Investigator

Vaibhav Sahai
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Vaibhav Sahai, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19
Study Completion Date2029-04

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

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