Clinical Trials Logo
  1. Home
  2. Tenosynovial Giant Cell Tumor
  3. NCT04635111

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

Tenosynovial Giant Cell Tumor Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

This FDA post-marketing requirement study will 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) for symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience hepatotoxicity. A liver biopsy will be collected from enrolled patients for central laboratory analysis of macrophage and immune cell profiles to investigate possible mechanisms of the hepatotoxicity. Additionally, 4 blood samples will be collected to evaluate liver function, other relevant safety tests, peripheral immune cells, and for pharmacogenomic testing. Enrolled patients will be followed at least yearly for 10 years to assess long-term risk of hepatic failure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04635111
Study type Observational [Patient Registry]
Source Daiichi Sankyo, Inc.
Contact Daiichi Sankyo Contact for Clinical Trial Information
Phone 908-992-6400
Email CTRinfo@dsi.com
Status Recruiting
Phase
Start date January 7, 2021
Completion date March 2036
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04488822 - A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT Phase 3
Active, not recruiting NCT01207492 - Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor Phase 2
Terminated NCT04938180 - A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients Phase 2
Completed NCT04526704 - Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib Phase 4
Active, not recruiting NCT05059262 - Study of Vimseltinib for Tenosynovial Giant Cell Tumor Phase 3
Active, not recruiting NCT04731675 - An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee Phase 2
Completed NCT02371369 - Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) Phase 3
Recruiting NCT04703322 - A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan Phase 2
Completed NCT02471716 - Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor Phase 1/Phase 2
Recruiting NCT05349643 - A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT Phase 2
Recruiting NCT04192344 - A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor Phase 1
Terminated NCT02673736 - A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor Phase 1
Active, not recruiting NCT03069469 - Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor Phase 1/Phase 2
Terminated NCT01804530 - Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT05804045 - Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) Phase 3