RECRUITING

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

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

A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon optional liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.

Official Title

A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

Quick Facts

Study Start:2021-01-07
Study Completion:2036-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04635111

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. * Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
  2. * Age ≥18 years old
  3. * Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:
  4. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \>2 × ULN
  5. * Isolated TBIL \>2 × ULN (excluding patients with Gilbert's syndrome)
  6. * Isolated AST or ALT \>10 × ULN
  7. * Alkaline phosphatase (ALP) \>2 x ULN with gamma-glutamyl transferase (GGT) \>2 x ULN
  8. * Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program
  1. * Not applicable

Contacts and Locations

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
908-992-6400
CTRinfo@dsi.com

Principal Investigator

Global Clinical Leader
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

Kamalesh K Sankhala MD INC
Santa Monica, California, 90403
United States
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403
United States
UCLA Hematology and Oncology
Santa Monica, California, 90404
United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90602
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Montefiore Medical Center
New York, New York, 10467
United States
OSU - James Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Kelsey Seybold Clinic - Pearland
Houston, Texas, 77014
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

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 Date2021-01-07
Study Completion Date2036-06-01

Study Record Updates

Study Start Date2021-01-07
Study Completion Date2036-06-01

Terms related to this study

Keywords Provided by Researchers

  • Hepatotoxicity
  • Tenosynovial Giant Cell Tumor
  • Pexidartinib
  • TURALIO™

Additional Relevant MeSH Terms

  • Hepatotoxicity
  • Tenosynovial Giant Cell Tumor