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Trial NCT04635111

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

Phase
Not given
Sponsor
Daiichi Sankyo
Conditions
Hepatotoxicity; Tenosynovial Giant Cell Tumor
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 × ULNHepatic * 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

Restrictions found (1)

  • HepaticConditionalinclusion

    AST or ALT >3 x ULN with TBIL >2 x ULN

    Show in the text

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute · Boston, Suffolk County