Actively Recruiting
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Led by Daiichi Sankyo · Updated on 2025-10-06
30
Participants Needed
8
Research Sites
803 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 tenosynovial giant cell tumor (TGCT) causing severe morbidity or functional limitations and not amenable to surgery
- Age 18 years or older
- At least one liver test abnormality due to TURALIO14 exposure: AST or ALT >3 times upper limit of normal (ULN) with total bilirubin >2 times ULN, or isolated total bilirubin >2 times ULN (excluding Gilbert's syndrome), or isolated AST or ALT >10 times ULN, or alkaline phosphatase >2 times ULN with gamma-glutamyl transferase >2 times ULN
- Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO14 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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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Withdrawn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Withdrawn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
CONTACT
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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