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Clinical Trials in the USA / NCT04635111
Recruiting Observational

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

NCT04635111 · tracked via the Priya Life Science USA tracker
Sponsor
Daiichi Sankyo
Phase
Observational
Started
2021-01-07
Last updated
2025-10-06

Condition(s) studied

HepatotoxicityTenosynovial Giant Cell Tumor

Investigational drug(s) / intervention(s)

TURALIO™ →

TURALIO™: This is a non-interventional, observational study to evaluate long-term risk of hepatic failure associated with TURALIO™ (pexidartinib) treatment. No study medication will be provided to the participants.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Frequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib) — Baseline up to 10 years
    Hepatic failure is defined as severe liver injury with encephalopathy and impaired synthetic function (INR \>= 1.5) as well as liver transplant and hepatic-related death.

Trial sites (8)

FacilityCityRegionStatus
Kamalesh K Sankhala MD INC Santa Monica California Recruiting
Sarcoma Oncology Research Center LLC Santa Monica California Not Yet Recruiting
UCLA Hematology and Oncology Santa Monica California Recruiting
The Oncology Institute of Hope and Innovation Whittier California Withdrawn
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Montefiore Medical Center New York New York Withdrawn
OSU - James Comprehensive Cancer Center Columbus Ohio Recruiting
Kelsey Seybold Clinic - Pearland Houston Texas Not Yet Recruiting

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Other trials for the same condition

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor Active, not recruiting
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) Active, not recruiting
MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib Recruiting
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor Recruiting
Study of Vimseltinib for Tenosynovial Giant Cell Tumor Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04635111 on ClinicalTrials.gov ↗ ← All trials in the USA