Actively Recruiting
A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO14 (Pexidartinib) Treatment
Led by Daiichi Sankyo · Updated on 2025-10-06
30
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term risk of liver failure linked to TURALIO14 (pexidartinib) treatment in patients with symptomatic tenosynovial giant cell tumor (TGCT) who have severe symptoms or functional problems and cannot improve with surgery. This study also explores how liver damage happens by examining liver biopsy samples from patients who have or had liver toxicity while on TURALIO14. The goal is to understand liver injury mechanisms and assess safety over time. This is a non-interventional, observational study where no study medication is given. Participants have experienced liver test abnormalities from TURALIO14 treatment. Optional liver biopsies will be taken for detailed analysis of immune cells in the liver. Blood samples will also be collected to monitor liver function, safety, immune cells, and genetics. Participants will be followed yearly for up to 10 years to track liver health and potential failure after stopping TURALIO14. During the study, participants will provide blood samples and may choose to have a liver biopsy for further testing. Researchers will assess liver test results and monitor for signs of liver failure, liver transplant need, or death. Follow-up visits occur at least once per year for 10 years to observe long-term effects. The main outcome measured is how often liver failure occurs after stopping TURALIO14, helping to better understand long-term safety in this group.
CONDITIONS
Brief Title
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
- Age 6518 years old
- Emergence of at least one of the following liver test abnormalities due to TURALIO14 (pexidartinib) exposure:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 �d7 upper limit of normal (ULN) with concurrent total bilirubin (TBIL) >2 �d7 ULN
- Isolated TBIL >2 �d7 ULN (excluding patients with Gilbert's syndrome)
- Isolated AST or ALT >10 �d7 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 TURALIO14 (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who have experienced hepatotoxicity due to TURALIO™ (pexidartinib) treatment are followed to evaluate the long-term risk of hepatic failure and to monitor liver function and safety.
At least yearly visits for up to 10 years
Trial Site Locations
Total: 8 locations
1
Kamalesh K Sankhala MD INC
Santa Monica, California, United States, 90403
Actively Recruiting
2
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States, 90403
Not Yet Recruiting
3
UCLA Hematology and Oncology
Santa Monica, California, United States, 90404
Actively Recruiting
4
The Oncology Institute of Hope and Innovation
Whittier, California, United States, 90602
Withdrawn
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Montefiore Medical Center
New York, New York, United States, 10467
Withdrawn
7
OSU - James Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Kelsey Seybold Clinic - Pearland
Houston, Texas, United States, 77014
Not Yet Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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