AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target.
研究概览
简要总结
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).
For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.
详细描述
Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)].
One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IGR) and will recruit up to 10 patients.
Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target, same or different from those listed above, e.g. in AXL gene, arising from pan-genome trials.
- ALCL, adults and children, ALK-translocated
- Colorectal cancer, adults, ALK-translocated
- Colorectal cancer, adults, MET amplified
- Colorectal cancer, adults, MET mutated
- NSCLC, adults, MET amplified
- NSCLC, adults, ROS1-translocated
- Breast cancer, adults, ALK-translocated
- Gastric cancer, adults, MET amplified
- Cholangiocarcinoma, adults, ROS1-translocated
- Ovarian cancer, adults, MET amplified
- Clear cell renal cell carcinoma, adults, ALK-translocated
- Clear cell renal cell carcinoma, adults, ALK-amplified
- Papillary renal cell carcinoma, adults, MET mutated (+ MET amplified)
- Hepatocarcinoma, adults, MET amplified
- Neuroblastoma, adults and children, ALK-amplified + ALK mutated
- IMT, adults and children, ALK-translocated
- Rhabdomyosarcoma (alveolar and embryonal), adults and children, ALK-amplified
- Glioblastoma, adults, MET amplified. This cohort will only be open after amendment
- Anaplastic thyroid cancer, adults, ALK mutated
- Thyroid cancer (follicular + medullary + papillary), adults, MET mutated
- Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target, same or different from those listed above
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
- One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CRIZOTINIB
All eligible patients entering the study will receive oral crizotinib as monotherapy
干预措施: Crizotinib (Drug)
结局指标
主要结局
The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target.
时间窗: Determined after 8 weeks (2 cycles) of treatment
Anti-tumor activity of crizotinib, as the primary objective of the trial, will be carried out by the determination of the objective response assessed in each cohort defined by a pathology associated with a crizotinib target alteration. The objective response is defined as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The objective response after 2 cycles (8 weeks) will be reported to define a success in the 2-stage design.
次要结局
- The safety profile of crizotinib.(Safety profile will be assessed during the whole treatment period (6 months expected in average) followed by a 2-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart)
- Disease control rate(After 8 weeks (2 cycles) and 16 weeks (4 cycles) of treatment)
- response duration(interval between the objective response (CR or PR) and time of progression, recurrence or death)
- Progression-free survival(from registration until time of disease progression or death)
- Overall survival(from registration until date of death)