NCT03026881Unknown1 期
An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
研究概览
简要总结
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
- •Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
- •At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
- •Subjects who have overall good overall general condition.
- •Signed informed consent.
排除标准
- •Subjects who received any previous treatment with any PARP inhibitors.
- •Subjects who received any previous treatment with any taxanes.
- •More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- •Less than 4 weeks from the last clinical trial.
- •Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
- •Unstable hypertension.
- •Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
- •Subjects with brain metastases.
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- •Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product.
- •Ongoing infection (determined by investigator).
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- •Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
Fluzoparib + Apatinib + Paclitaxel
Experimental
干预措施: Fluzoparib (Drug)
Fluzoparib + Apatinib + Paclitaxel
Experimental
干预措施: Apatinib (Drug)
Fluzoparib + Apatinib + Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
时间窗: through study completion, an average of 6 months
DLT and safety defined by CTC version 4.0
次要结局
- Maximum plasma concentration (Cmax)(Up to 33 days)
- Overall Response Rate (ORR)(through study completion, an average of 6 months)
- Terminal half life (t1/2)(Up to 33 days)
- Best of ORR(through study completion, an average of 6 months)
- Time to Progression (TTP)(From date of enrollment until the date of first objective progression, assessed up to 9 months)
- Volume of distribution (V/F)(Up to 33 days)
- Disease Control Rate (DOR)(through study completion, an average of 6 months)
- Progression Free Survival (PFS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months)
- Area under the plasma concentration-time curve (AUC）(Up to 33 days)
- Plasma Clearance (CL/F)(Up to 33 days)
研究者
研究点 (1)
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