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

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Brief Summary

A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.

Study Type
Observational [Patient Registry]
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
21-000498
Category
Kidney Cancer
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04635111
For detailed technical eligibility, visit ClinicalTrials.gov.