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

  • STATUS
    Recruiting
  • End date
    Mar 20, 2036
  • participants needed
    30
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 20 June 2022

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.

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 patients who received or are receiving TURALIO™ (pexidartinib) for symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience hepatotoxicity. A liver biopsy will be collected from enrolled patients for central laboratory analysis of macrophage and immune cell profiles to investigate possible mechanisms of the hepatotoxicity. Additionally, 4 blood samples will be collected to evaluate liver function, other relevant safety tests, peripheral immune cells, and for pharmacogenomic testing. Enrolled patients will be followed at least yearly for 10 years to assess long-term risk of hepatic failure.

Details
Condition Hepatotoxicity, Tenosynovial Giant Cell Tumor
Treatment TURALIO™
Clinical Study IdentifierNCT04635111
SponsorDaiichi Sankyo, Inc.
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

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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