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NCT04635111 · ClinicalTrials.gov registry record

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

A clinical trial of Tenosynovial Giant Cell Tumor and Hepatotoxicity, sponsored by Daiichi Sankyo.

Recruiting
Registry status
30
Enrollment target
8
Study locations

NCT04635111 is a study of Tenosynovial Giant Cell Tumor and Hepatotoxicity that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 30 participants, below the 114-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 5 states.

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The verdict

NCT04635111, a study of Tenosynovial Giant Cell Tumor and Hepatotoxicity, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
30 participants
Enrollment target
8
Study locations

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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2021-01-07
Est. Completion 2036-06-01

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT04635111

The ClinicalTrials.gov registry entry for NCT04635111 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (74% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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.

NCT04635111 reports 8 study locations spanning 5 distinct geographic areas - top geographies include California, Massachusetts, New York.

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.

What interventions are being tested in trial NCT04635111?

The interventions under investigation include: TURALIO™ (DRUG).

Who is sponsoring clinical trial NCT04635111?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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