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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Daiichi Sankyo
Study ID
NCT04635111
Status
Recruiting
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Conditions

  • Hepatotoxicity
  • Tenosynovial Giant Cell Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TURALIO™ — DRUG
    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 Details

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.

Key Dates

Start date
Jan 7, 2021
Status verified
Sep 2025
Primary completion
Jun 1, 2036
Completion
Jun 1, 2036

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Kamalesh K Sankhala MD INCSanta MonicaCalifornia90403
Principal Investigator
Sarcoma Oncology Research Center LLCSanta MonicaCalifornia90403
Principal Investigator
UCLA Hematology and OncologySanta MonicaCalifornia90404
Principal Investigator
The Oncology Institute of Hope and InnovationWhittierCalifornia90602-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Principal Investigator
Montefiore Medical CenterNew YorkNew York10467-
OSU - James Comprehensive Cancer CenterColumbusOhio43210
Principal Investigator
Kelsey Seybold Clinic - PearlandHoustonTexas77014
Principal Investigator

Find similar trials in Santa Monica, CA

By research site
Kamalesh K Sankhala MD INC· Santa Monica, CASarcoma Oncology Research Center LLC· Santa Monica, CAUCLA Hematology and Oncology· Santa Monica, CAThe Oncology Institute of Hope and Innovation· Whittier, CADana-Farber Cancer Institute· Boston, MAMontefiore Medical Center· New York, NY

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