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Long-term Study of TURALIO™ and Liver Health

This observational study is looking at the long-term risk of liver failure in people who have taken TURALIO™ (pexidartinib) for tenosynovial giant cell tumor (TGCT), a type of tumor that affects joints. You might be able to join if you are an adult with symptomatic TGCT not treatable by surgery, and you've experienced certain liver test abnormalities (like high AST or ALT levels) after taking TURALIO™. The study aims to understand how often liver failure happens after stopping TURALIO™ and to learn more about why liver injury might occur, possibly through optional liver biopsies. The study plans to enroll 30 participants.

Study design
This is an observational study with no specified phase, designed to follow 30 participants. It is not testing a new treatment but rather observing the long-term effects of an existing one.
What's involved
You would provide four blood samples and potentially an optional liver biopsy. You would also be followed at least yearly for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed at least yearly for up to 10 years to assess the long-term risk of liver failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04635111

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

Recruiting
Not specifiedAges 18+Observational
Daiichi Sankyo
~30 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:TURALIO™

At a glance

Recruiting sites
4 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib)
Measured over Baseline up to 10 years

Conditions

Hepatotoxicity
Tenosynovial Giant Cell Tumor

Explore related trials

Tenosynovial Giant Cell Tumor

NCT04635111

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Kamalesh K Sankhala MD INC

    Santa Monica, Californiano site contact published

    Recruiting

  • Kelsey Seybold Clinic - Pearland

    Houston, Texasno site contact published

    Not yet recruiting

  • OSU - James Comprehensive Cancer Center

    Columbus, Ohiono site contact published

    Recruiting

  • Sarcoma Oncology Research Center LLC

    Santa Monica, Californiano site contact published

    Not yet recruiting

  • UCLA Hematology and Oncology

    Santa Monica, Californiano site contact published

    Recruiting

  • Montefiore Medical Center

    New York, New Yorkno site contact published

    Withdrawn

  • The Oncology Institute of Hope and Innovation

    Whittier, Californiano site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo

Who to contact

Daiichi Sankyo Contact for Clinical Trial Information
[email protected]
908-992-6400
Email the study team

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Eligibility criteria

Inclusion

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

Not applicable

What this trial measures

  • 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.