NCT02048488已完成1 期
A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Tesaro, Inc.
- 入组人数
- 72
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including:
- Anaplastic lymphoma kinase (ALK)
- The tropomyosin-related kinases TRKA, TRKB, and TRKC
This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.
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
- •To be considered eligible to participate in this study, all of the following requirements must be met:
- •Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy
- •All patients must have confirmation of either ALK positive or TRK positive status.
- •Patients in Phase 1 will not be required to have measurable disease. All patients in Phase 2a will be required to have measurable disease by RECIST.
- •All patients enrolled in this study must have tumor tissue available.
- •Patient (male or female) must be ≥ 18 years of age (except where age of majority is 16 years in a particular country, such as the United Kingdom).
- •Patient must have performance status ≤2 on the ECOG Performance Scale.
- •Patient must have an estimated life expectancy of at least 3 months.
- •Patients must have adequate organ function.
- •For patients previously treated with myelosuppressive therapy, at least 3 weeks must have elapsed and toxicity must have recovered to grade 1 or baseline. Non-myelosuppressive therapy patients must have recovered from all treatment-related toxicities. Fourteen days must have elapsed since palliative radiation for bone metastasis.
- •Female patients of childbearing potential must have a negative serum pregnancy test and use adequate birth control for the duration of study participation and for 3 months after the last dose of study drug.
- •The patient or his or her legal representative must be able to read, understand, and provide signed informed consent.
- •Patient is able to understand the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Patients will not be deemed eligible for entry into this study if any of the following criteria are met:
- •Patient has leukemia.
- •Patient is a pregnant or lactating female.
- •Patient has uncontrolled congestive heart failure, angina, or has had a myocardial infarction in the preceding 3 months.
- •Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade, or QTc interval >450 msec.
- •Patients with risk factors for Torsade de point and patients receiving concomitant medication with QT-prolonging medicines.
- •Patient has an uncontrolled concurrent medical condition or disease.
- •Patient has undergone bone marrow or stem cell transplantation in the past 6 months.
- •Patient has a known hypersensitivity to the components of TSR-011 or the excipients.
- •Patient has active or uncontrolled infection.
- •Patient has a known psychiatric or substance abuse disorder.
- •Patient has active second primary malignancy.
- •Patient is observed to have a clinically active central nervous system (CNS) metastases or carcinomatous meningitis.
- •Patient has any other severe concurrent disease which, in the judgment of the Investigator, would preclude study participation.
- •Patient is known to be HIV positive or who has an AIDS-related illness.
- •Patient has a known history of or active (treated or not) Hepatitis B or C.
- •Patient has presence of ascites causing significant symptoms.
- •A patient must stop taking any prescription, over-the-counter, or herbal remedy known to be an inhibitor or inducer of CYP3A4/5.
研究组 & 干预措施
Experimental Drug TSR-011
Experimental
Experimental Drug TSR-011
干预措施: TSR-011 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Approximately 2 years
次要结局
- Recommended Phase 2 Dose (RP2D)(approximately 2 years)
- Area Under the Concentration-Time Curve (AUC)(Day 1: 0-24 hrs after first dose; pre-dose on days 8 & 15; day 29: 0-24 hours)
- Response Rate (RR)(approximately 2 years)
- Progression Free Survival (PFS)(approximately 2 years)
- Dose limiting toxicity (DLT)(28 days after first dose)
- Maximum Tolerated Dose (MTD)(28 days after first dose)
研究者
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