Clinical trial · Interventional
A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT
A Phase 2, Multicenter, Open-label, Non-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DCC-3014 in Japanese Subjects With Tenosynovial Giant Cell Tumor (TGCT)
NCT07832747CI-TRIAL-00126533not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tenosynovial Giant Cell Tumor | Tenosynovial Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCC-3014 | Drug | Vimseltinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCC-3014
- interventionNames
- Drug: DCC-3014
Primary outcomes (1)
- measure
- ORR at Week 24
- timeFrame
- at Week 24
- description
- Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
Secondary outcomes (13)
- measure
- Adverse events
- timeFrame
- through study completion, an average of 3 year
- description
- To assess the safety of DCC-3014 in Japanese patients with TGCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology/pathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM) * TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity * Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period * Other protocol defined inclusion criteria may apply Exclusion Criteria: * Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure) * QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females, or history of long QT syndrome * Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis * Other protocol defined exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.