RECRUITING

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

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

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

Official Title

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

Quick Facts

Study Start:2024-07-19
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06430528

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Endogenous Cushing syndrome, either following surgery or not candidates for surgery
  2. * Under consideration to receive osilodrostat as part of their clinical care
  3. * Able to provide informed consent.
  1. * Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
  2. * A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.

Contacts and Locations

Study Contact

Thaira Blanco Varela
CONTACT
734-647-5661
tbv@med.umich.edu
Eyad Alsafadi
CONTACT
734-647-5661
alsafade@med.umich.edu

Principal Investigator

Richard Auchus, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Richard Auchus, MD, PhD, 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 Date2024-07-19
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-07-19
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Osilodrostat
  • Glucocorticoid
  • Methylprednisolone
  • Medrol

Additional Relevant MeSH Terms

  • Endogenous Cushing Syndrome
  • Adrenal Insufficiency
  • Hypercortisolism