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

Launched by DAIICHI SANKYO · Nov 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a medication called TURALIO™ (pexidartinib) on the liver in patients with a rare type of tumor known as tenosynovial giant cell tumor (TGCT). Researchers want to understand how this medication might cause liver problems, specifically looking for signs of liver injury through liver biopsy information. The trial is currently recruiting participants who are at least 18 years old and have experienced specific liver test abnormalities after taking TURALIO™.

Eligible participants will be those who have TGCT that causes significant discomfort or limits their daily activities, and who cannot improve with surgery. If you join the study, you can expect to go through necessary procedures and have regular follow-ups to monitor your health over time. This trial is important because it aims to ensure the safety of TURALIO™ for those who need it while better understanding how it may affect the liver.

Gender

ALL

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