A Phase 2 Study of Apatinib Combined With Temozolomide in the Treatment of Advanced Melanoma Patients After Conventional Treatment Failure
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression Free Survival（PFS）
研究概览
简要总结
30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.
详细描述
In this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. The therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib, 500 mg, qd, po, d1-28, Every 28 days for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. So we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.
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
- •Age 18-70 years old；
- •ECOG performance scale 0-1；
- •Life expectancy of more than 3 months；
- •Histologically or cytologic confirmed melanoma；
- •Temozolomide has not been previously treated；
- •Patients who have failed at least one systemic treatment regimen： including but not limited to patients receiving immunotherapeutics such as PD-1 monoclonal antibodies, PDL-1 monoclonal antibodies, ipilimumab, C-kit inhibitors, Braf inhibitors, and molecular targeted drugs.
- •For results of blood routine test and biochemical tests： Hgb>100g/L, ANC>2.0×109/L, PLT>100×109/L, Serum Total bilirubin ≤ 1.5 X UNL, ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）, Serum Creatine ≤ 1.5 x UNL；
- •Informed consent；
- •Willingness and ability to comply with scheduled visits.
排除标准
- •Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)；
- •With ≥grade 2 coronary heart disease, arrhythmia (including QTc interval prolongation male ≥450 ms, women ≥470 ms)；
- •Imaging studies have shown that the tumor has been infringing on an important perivascular or when the researcher determines that the patient's tumor has a high risk of fatal hemorrhage during treatment；
- •Abnormal Coagulation (INR>1.5, PT>UNL+4 seconds), with tendency of bleed or receiving the therapy of thrombolysis or anticoagulation.；
- •Urine protein ≥++ or confirmed >1.0 g by the 24h quantity；
- •Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures；
- •A history of psychotropic substance abuse and can not be abstinent or mental disorders ；
- •There are serious concomitant diseases that endanger patient safety or affect the patient in completing the study；
- •Patients participating in other clinical trials simultaneously；
- •Other situations that the researchers considered unsuitable for this study；
- •Confirmed brain metastasis.
研究组 & 干预措施
Apatinib plus Temozolomide
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,apatinib+temozolomide.
干预措施: Apatinib (Drug)
Apatinib plus Temozolomide
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,apatinib+temozolomide.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression Free Survival（PFS）
时间窗: 12 months
PFS is evaluated in 12 months since the treatment began
次要结局
- Disease Control Rate(DCR)(12 months)
- Objective Response Rate(ORR)(12 months)
- Overall Survival(OS)(12 months)
- Safety and Tolerability as measured by adverse events(12 months)
研究者
Jun Guo
Director of department of renal cancer and melanoma
Peking University Cancer Hospital & Institute