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

Description

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

Conditions

Hepatotoxicity, Tenosynovial Giant Cell Tumor

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Study Overview

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Study Details

Study overview

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

A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

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

Condition
Hepatotoxicity
Intervention / Treatment

-

Contacts and Locations

Santa Monica

Kamalesh K Sankhala MD INC, Santa Monica, California, United States, 90403

Santa Monica

Sarcoma Oncology Research Center LLC, Santa Monica, California, United States, 90403

Santa Monica

UCLA Hematology and Oncology, Santa Monica, California, United States, 90404

Whittier

The Oncology Institute of Hope and Innovation, Whittier, California, United States, 90602

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Montefiore Medical Center, New York, New York, United States, 10467

Columbus

OSU - James Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Houston

Kelsey Seybold Clinic - Pearland, Houston, Texas, United States, 77014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Not applicable

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daiichi Sankyo,

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

2036-03-01