A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 gender, age ≥18 years at screening.
- •Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- •Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-
- •Life expectancy ≥6 months.
- •Signed ICF for voluntary participation in the study and good compliance.
排除标准
- •Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- •Hematologic malignancies.
- •Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day
- •Untreated brain metastases; or with leptomeningeal metastasis.
- •Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- •Severe cardiovascular disorders or interventions within 6 months
- •Have arterial/venous thrombosis within 6 months
- •Known bleeding disorders, platelet dysfunction
- •Severe haemorrhage during screening
- •Acute or uncontrolled hepatitis B&C infection
- •Human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
Part A: Hetrombopag Olamine
干预措施: Hetrombopag Olamine (Drug)
Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo
干预措施: Hetrombopag Olamine ；Hetrombopag Olamine Placebo (Drug)
结局指标
主要结局
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
时间窗: around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months
时间窗: around 6 months
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months
时间窗: around 6 months
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years
时间窗: around 3 years
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
时间窗: around 3 years.
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;
时间窗: around 3 years;
次要结局
- Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;(around 3 years;)
- platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;(around 3 years;)
- Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;(around 3 years;)
- Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.(around 3 years.)
- Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.(around 3 years.)