At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed tenosynovial giant cell tumor (TGCT) that is unresectable
- ✓Measurable disease by RECIST 1.1 with at least one lesion ≥2 cm
- ✓ECOG Performance Status 0 or 1
- ✓Adequate organ and bone marrow function
- ✕Previous treatment with highly selective CSF-1/CSF-1R inhibitors (prior imatinib and nilotinib are allowed)
- ✕Known metastatic TGCT
- ✕Active malignancy requiring treatment that may affect study participation or outcomes
- ✕Impaired cardiac function or clinically significant cardiac disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor
In Brief
A Phase 3 clinical trial evaluating Pimicotinib(ABSK021) and Placebo for Tenosynovial Giant Cell Tumor and 2 related conditions. Active but no longer recruiting, targeting 94 participants across 40 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
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