RECRUITING

Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults with Recurrent, Refractory or Progressive Osteosarcoma

Conditions

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

MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.

Official Title

A Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib As a Single Agent in Adolescents and Adults with Recurrent, Refractory or Progressive Osteosarcoma

Quick Facts

Study Start:2023-05-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05588648

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:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, 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

Kristen VanHeyst, DO
CONTACT
(216) 844-3345
Kristen.VanHeyst@UHhospitals.org

Study Locations (Sites)

UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: MedPacto, Inc.

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 Date2023-05-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Osteosarcoma