NCT07832747尚未招募2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ORR at Week 24
研究概览
简要总结
To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DCC-3014
Experimental
干预措施: DCC-3014 (Drug)
结局指标
主要结局
ORR at Week 24
时间窗: at Week 24
Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1
次要结局
- Adverse events(through study completion, an average of 3 year)
- ORR per TVS (Tumor Volume Score) at Week 24(at Week 24)
- Change from Baseline in Range of Motion (ROM) at Week 24(at Week 24)
- Change from baseline in PROMIS Physical Function score at Week 24(at Week 24)
- Change from baseline in the Worst Stiffness NRS score at Week 24(at Week 24)
- Change from baseline in EQ-VAS (self-rated health scale) at Week 24(at Week 24)
- Proportion of participants with at least 30% improvement in mean BPI Worst Pain NRS score, without a 30% or greater increase in narcotic analgesic use at Week 24(at Week 24)
- Best of response per RECIST v1.1(through study completion, an average of 3 year)
- Best of response per TVS(through study completion, an average of 3 year)
- Duration of response per RECIST v1.1(through study completion, an average of 3 year)
- Duration of response per TVS(through study completion, an average of 3 year)
- Plasma DCC-3014 concentration(from Week 0 to Week 24)
- Plasma DP-7005 concentration(from Week 0 to Week 24)
研究者
研究点 (1)
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