A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Recruiting now
Conditions studied: Hepatotoxicity, Tenosynovial Giant Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT04635111
- Run by
- Daiichi Sankyo
- People needed
- 30
- Starts
- 2021-01-07
- Expected to finish
- 2036-06-01
- Last updated by the study team
- 2025-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Not applicable
Where it is running
- Kamalesh K Sankhala MD INC — Santa Monica, California, United States (enrolling)
- UCLA Hematology and Oncology — Santa Monica, California, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- OSU - James Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
- Kelsey Seybold Clinic - Pearland — Houston, Texas, United States
- Sarcoma Oncology Research Center LLC — Santa Monica, California, United States
- Montefiore Medical Center — New York, New York, United States
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
Full record on ClinicalTrials.gov
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