测试克唑替尼作为 ALK 基因改变癌症的潜在靶向治疗（MATCH-Subprotocol F）
MATCH 治疗子方案 F：克唑替尼治疗伴有 ALK 重排的肿瘤（肺腺癌或 ALCL 除外）患者
This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ALK rearrangement. Crizotinib may stop the growth of cancer cells by blocking the ALK protein which may be needed for cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.
研究概览
详细说明
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive crizotinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19103
- ECOG-ACRIN Cancer Research Group
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
- Patients must have an ALK rearrangement as defined via the MATCH Master Protocol
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Exclusion Criteria:
- Patients must not have non small cell lung cancer or anaplastic large cell lymphoma (ALCL)
- Patients with a history of interstitial lung disease or pneumonitis are excluded
- Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition
- Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922
- Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment
- Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment (crizotinib)
Patients receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity |
Given PO
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate (ORR)
大体时间：Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was calculated for ORR. |
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-month Progression-free Survival (PFS) Rate
大体时间：Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
|
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point. |
Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
|
|
Progression Free Survival (PFS)
大体时间：Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. |
Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
|
合作者和调查者
调查人员
- 首席研究员：Alice T Shaw、ECOG-ACRIN Cancer Research Group
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCI-2020-03270
- U10CA180820 (美国 NIH 拨款/合同)
- U24CA196172 (美国 NIH 拨款/合同)
- NCI-2020-03270 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- EAY131-F (其他标识符：CTEP)
- EAY131-F (其他标识符：ECOG-ACRIN Cancer Research Group)
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