NCT05716087进行中（未招募）2 期
An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma
Guangzhou Lupeng Pharmaceutical Company LTD.43 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年2月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 43
- 主要终点
- Overall Response Rate
研究概览
简要总结
This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.
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
- •Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
- •At least one measurable lesion.
- •Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD
- •Adequate hematologic function.
- •Adequate hepatic and renal function.
- •Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.
排除标准
- •Received non-covalent BTK inhibitor treatment.
- •Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
- •Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
- •Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
- •Disease affects the central nervous system.
- •Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
研究组 & 干预措施
Rocbrutinib
Experimental
Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
干预措施: Rocbrutinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
次要结局
- Overall Response Rate(Up to 24 Months)
- Complete remission rate(Up to 24 Months)
- Progression Free Survival(Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.)
- Overall survival(Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.)
- Duration of Response (DOR)(Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.)
- Time to Response (TTR)(Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.)
- Safety Assessment(From first dose of study drug to 28 days after last dose of study drug)
- Maximum Observed Plasma Concentration (Cmax)(Up to 24 hours post dose)
- Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)(Up to 24 hours post dose)
- Maximum Observed Plasma Concentration (Tmax)(Up to 24 hours post dose)
- Half-life period (T1/2)(Up to 24 hours post dose)
- Quality of life (QoL)(Up to 24 Months)
研究者
研究点 (43)
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