Recruiting

Turalio

Sponsor:

Daiichi Sankyo

Code:

NCT04635111

Conditions

Hepatotoxicity

Tenosynovial Giant Cell Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TURALIO™

Study Details

Brief 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.

Conditions

Hepatotoxicity

Tenosynovial Giant Cell Tumor

Study ID

NCT04635111

Start date

Jan 7, 2021

Status verified date

Sep, 2025

Completion date

Jun 1, 2036

Anticipated

Primary completion date

Jun 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Symptomatic TGCT Participants

Adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience moderate or severe hepatotoxicity due to use of TURALIO™ (pexidartinib).

Interventions

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.

Primary outcome measure

  • Frequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib) [ Time Frame: Baseline up to 10 years ]

Central Contacts and Locations

Central contacts

Daiichi Sankyo Contact for Clinical Trial Information

908-992-6400CTRinfo@dsi.com

Locations

Kamalesh K Sankhala MD INC

Recruiting

Santa Monica, California, United States, 90403

UCLA Hematology and Oncology

Recruiting

Santa Monica, California, United States, 90404

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

OSU - James Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Daiichi Sankyo

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Keywords

  • Hepatotoxicity
  • Tenosynovial Giant Cell Tumor
  • Pexidartinib
  • TURALIO™

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Daiichi Sankyo on 2025-10-06.