To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
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
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
Single group
DCC-3014
DrugDCC-3014 will be orally administered at a dose of 30 mg twice weekly.
ORR at Week 24
Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
Adverse events
To assess the safety of DCC-3014 in Japanese patients with TGCT
ORR per TVS (Tumor Volume Score) at Week 24
Tumor response will be assessed by an independent radiological reviewer per TVS.
Change from Baseline in Range of Motion (ROM) at Week 24
Active and passive ROM of the affected and non-affected joints will be assessed
Change from baseline in PROMIS Physical Function score at Week 24
PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score
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