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A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
NCT04635111 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG TURALIO™
Study Locations (8)
California
- Kamalesh K Sankhala MD INC — Santa Monica
- Sarcoma Oncology Research Center LLC — Santa Monica
- UCLA Hematology and Oncology — Santa Monica
- The Oncology Institute of Hope and Innovation — Whittier
Massachusetts
- Dana-Farber Cancer Institute — Boston
New York
- Montefiore Medical Center — New York
Ohio
- OSU - James Comprehensive Cancer Center — Columbus
Texas
- Kelsey Seybold Clinic - Pearland — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2036-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04635111
The ClinicalTrials.gov registry entry for NCT04635111 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 1 intervention — of which TURALIO™ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04635111 reports 8 study locations spanning 5 distinct geographic areas — top geographies include California, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04635111 about?
NCT04635111 is a clinical study titled "A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment". 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.
What is the current status of trial NCT04635111?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2021-01-07. Estimated completion is 2036-06-01.
What conditions does trial NCT04635111 study?
This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Hepatotoxicity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04635111?
The interventions under investigation include: TURALIO™ (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04635111?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04635111 being conducted?
This trial has 8 study locations across California, Massachusetts, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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