A Randomized, Double Blind Placebo-controlled Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia in Patients With Solid Tumor
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- efficacy of eltrombopag (50mg once daily)
研究概览
简要总结
The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of isolated chemotherapy-induced thrombocytopenia in patients with solid tumor .
详细描述
For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy of eltombopag . Each subject will be randomly assigned to either Arm A (eltombopag) or Arm B (placebo) in 2:1 ratio.
The primary objective is to compare the response rates of the two treatment arms, Therefore, the two-proportion z test will be considered and sample size can be chosen to achieve an 95% power for detecting a clinically meaningful difference at level of significance=0.05. A difference of 40% in clinical response is considered of clinically meaningful difference between the two treatment arms (75% for eltombopag vs. 35% for placebo). It requires a total sample of 83 subjects (55 for eltombopag and 28 for placebo). According to the 10% loss of screening failure, 90-100 subjects (60-67 for eltombopag and 30-33 for placebo) will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subjects aged ≥18 years
- •Diagnosed with solid tumor
- •On active chemotherapy with combined regimen
- •A baseline platelet count of <75,000/μL within 2 days of screening
- •Hb ≧ 9.0 g/dL
- •ANC ≧ 1,500/uL
- •GOT and GPT ≤ 3 x ULN
- •Serum bilirubin ≤ 1.5 x ULN
- •Albumin ≥ 2.5 g/dL
- •Adequate renal function for chemotherapy:
- •serum creatinine ≤ 1.5 × ULN (CTCAE Grade 1).
- •Be able to take oral medicine
- •ECOG performance ≤ 2
- •Has a negative urine or serum pregnancy test at screening and is willing to use contraceptive measures during medication of this trial (Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation and post-menopausal status) for patients with childbearing potential
- •Ability to participate and willingness to give written informed consent and to comply with the study restrictions
排除标准
- •Single agent chemotherapy or not having chemotherapy
- •Serious cardiac, cerebrovascular, or pulmonary disease that, in the opinion of the investigator, would preclude trial medication
- •Severe GI tract obstruction that require continuous NG decompression
- •Subjects with hemoglobinopathies, e.g. sickle cell anaemia, thalassemia major
- •Any prior history of arterial or venous thrombosis
- •Any disease condition associated with active bleeding or requiring anticoagulation, heparin or warfarin
- •Pre-existing cardiac disease (congestive heart failure New York Heart Association (NYHA) Grade III/IV), (See Appendix 1), or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec.
- •Seizure disorder that has not been well controlled
- •Pregnant or nursing women
- •Thyroid dysfunction not adequately controlled.
- •Within 2months prior to entering the study, been received radiotherapy to more than 20% bone marrow bearing sites.
- •Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted.
- •A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator is due to drugs chemically related to eltrombopag
- •Subjects taking anti-neoplastic and immunomodulatory medications (this includes mycophenolate mofetil, thymosine alpha, and extended courses of supraphysiologic doses of steroids)
研究组 & 干预措施
eltrombpag
Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days.
干预措施: Eltrombopag (Drug)
Eltrombopag/placebo
Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
efficacy of eltrombopag (50mg once daily)
时间窗: up to treatment eltrombopag 7 days
Evaluate the efficacy of eltrombopag (50mg once daily) compared to the placebo by assessment of response rate
次要结局
- safety and feasibility of 7-day eltrombopag(up to treatment eltrombopag 7 days)