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Clinical Trial Summary

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: - Whether the Pimicotinib(ABSK021) works well in patients with TGCT. - Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures: - Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1. - Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. - Receive the administration of Pimicotinib(ABSK021) till study end in study part 3. - Complete the study procedures speficied in the protocol, which is guided by researchers.


Clinical Trial Description

This study consists of part 1 and part 2. Part 1 is a double-blind phase, eligible patients will be randomized to Pimicotinib(ABSK021) treatment group or matching placebo group and will receive Pimicotinib(ABSK021) or matching placebo until completion of Part 1. Part 2 is an open-label treatment phase, and all patients entering this phase will receive open-label Pimicotinib(ABSK021) until completion of 24 weeks of dosing or withdrawal from the study. Part 3 is an open-label extension treatment phase, and patients who completed the part 2 and continuted to be eligible, will go to the Part 3. Patients will receive the open-label Pimicotinib(ABSK021) until all patients withdraw from the study, or the sponsor decides to terminate the study, whichever occurs first. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05804045
Study type Interventional
Source Abbisko Therapeutics Co, Ltd
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 27, 2023
Completion date June 2028

See also
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Completed NCT04526704 - Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib Phase 4
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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