🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

Recruitingn/aAges 18 Years - anyAllDaiichi Sankyo
NCT04635111 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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

What it tests

  • TURALIO™
📍

Where

8 sites
Kamalesh K Sankhala MD INC
Santa Monica, United States
Sarcoma Oncology Research Center LLC
Santa Monica, United States
UCLA Hematology and Oncology
Santa Monica, United States
The Oncology Institute of Hope and Innovation
Whittier, United States
Dana-Farber Cancer Institute
Boston, United States
Montefiore Medical Center
New York, United States
OSU - James Comprehensive Cancer Center
Columbus, United States
Kelsey Seybold Clinic - Pearland
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy