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

RECRUITINGSponsored by Daiichi Sankyo
Actively Recruiting
SponsorDaiichi Sankyo
Started2021-01-07
Est. completion2036-06-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT04635111

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

Age: 18 Years+Healthy volunteers 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

Conditions3

CancerHepatotoxicityTenosynovial Giant Cell Tumor

Locations8 sites

Kamalesh K Sankhala MD INC
Santa Monica, California, 90403
Principal Investigator
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403
Principal Investigator
UCLA Hematology and Oncology
Santa Monica, California, 90404
Principal Investigator
The Oncology Institute of Hope and Innovation
Whittier, California, 90602
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Principal Investigator

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