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
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
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Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County