A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 9
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
详细描述
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment.
The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
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
- •Male or female patients ≥18 years of age.
- •Patients with advanced gastrointestinal stromal tumors.
- •Subjects who have progressed or documented intolerance after previous treatments.
- •Sign informed consent, understand the Protocol and could follow the Protocol.
- •The subject had at least one measurable lesion.
- •Adequate organ function and bone marrow reserve
排除标准
- •Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- •Prior treatment with DCC-
- •Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-
- •Patient has known active central nervous system metastases.
- •New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
- •Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
- •Venous thrombotic events within 3 months before the first dose of investigational drug.
- •12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval syndrome.
- •Left ventricular ejection fraction (LVEF) <50% at screening.
- •Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- •Major surgeries within 4 weeks of the first dose of investigational drug.
- •Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
- •Active viral infections.
- •If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
- •Known allergy or hypersensitivity to any component of the investigational drug.
- •Gastrointestinal abnormalities.
- •Any active hemorrhages, excluding hemorrhoids or gum bleeding.
研究组 & 干预措施
DCC-2618
DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
干预措施: DCC-2618 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Approximately 10 months since the first subject enrolled.
Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).
次要结局
- Objective Response Rate (ORR)(Approximately 15 months since the first subject enrolled.)
- Overall Survival (OS)(Approximately 28 months since the first subject enrolled.)
- Time to Best Response (TBR)(Approximately 15 months since the first subject enrolled.)
- Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks(Approximately 15 months since the first subject enrolled.)