Status:
RECRUITING
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hepatotoxicity
Tenosynovial Giant Cell Tumor
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
This FDA post-marketing requirement study will evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon liver biopsy information among p...
Eligibility Criteria
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
Key Trial Info
Start Date :
January 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2036
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04635111
Start Date
January 7 2021
End Date
June 1 2036
Last Update
October 6 2025
Active Locations (8)
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1
Kamalesh K Sankhala MD INC
Santa Monica, California, United States, 90403
2
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States, 90403
3
UCLA Hematology and Oncology
Santa Monica, California, United States, 90404
4
The Oncology Institute of Hope and Innovation
Whittier, California, United States, 90602