NCT02568267进行中（未招募）2 期
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
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）
- 入组人数
- 534
- 试验地点
- 211
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
- •For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
- •Measurable or evaluable disease
- •Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
- •Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
- •- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
- •At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
- •At least 4 weeks must have elapsed since completion of antibody-directed therapy
- •Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
- •Adequate organ function as defined per protocol
- •Ability to swallow entrectinib intact
- •Other protocol specified criteria
排除标准
- •Current participation in another therapeutic clinical trial
- •Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
- •- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
- •History of other previous cancer that would interfere with the determination of safety or efficacy
- •Familial or personal history of congenital bone disorders, or bone metabolism alterations
- •Incomplete recovery from any surgery
- •History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
- •History of non-pharmacologically induced prolonged QTc interval
- •History of additional risk factors for torsades de pointes
- •Peripheral neuropathy Grade ≥ 2
- •Known active infections
- •Active gastrointestinal disease or other malabsorption syndromes
- •Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
- •Other protocol specified criteria
研究组 & 干预措施
ROS1-rearranged other solid tumor
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
NTRK/1/2/3-rearranged mCRC
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
ROS1-rearranged mCRC
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
NTRK1/2/3-rearranged NSCLC
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
ALK- or ROS1-rearranged NSCLC
Experimental
with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.)
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
ROS1-rearranged NSCLC
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
ALK-rearranged mCRC
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
NTRK1/2/3-rearranged other solid tumor
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
ALK-rearranged other solid tumor
Experimental
Oral entrectinib (RXDX-101)
干预措施: Entrectinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Approximately 24 months
Assessed by blinded independent central review (BICR) using RECIST v1.1
次要结局
- Clinical Benefit Rate(Approximately 24 months)
- Progression-free Survival(Approximately 30 months)
- Duration of Response(Approximately 24 months)
- Time to Response(Approximately 24 months)
- Intracranial Tumor Response(Approximately 24 months)
- Overall Survival(Approximately 36 months)
- Population PK(Approximately 24 months)
- Bone Biomarkers(Approximately 30 months)
- CNS Progression-free Survival(Approximately 24 months)
- Bone Growth and Bone Mineral Density(Approximately 30 months)
- Quality of Life(Approximately 24 months)
- Adverse Events(Approximately 36 months)
研究者
研究点 (211)
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