<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2013</study_start_year><condition>Patients with metastatic or unresectable locally advanced malignancies harboring specific genomic alterations regarding the biological crizotinib targets, and who are no more amenable to curative treatment</condition><condition>Liver carcinoma</condition><condition>Hematologic Neoplasms</condition><condition>Rhabdomyosarcoma</condition><condition>Glioblastoma</condition><condition>Colorectal cancer</condition><condition>Breast cancer</condition><condition>Neuroblastoma</condition><condition>Ovarian cancer</condition><condition>Thyroid cancer</condition><condition>Renal cell carcinoma</condition><condition>Non-small cell lung cancer</condition><condition>Anaplastic large cell lymphoma T- and-cell types</condition><condition>Inflammatory myofibroblastic tumour</condition><condition>Metastatic Cancer</condition><condition>Gastric cancer</condition><condition>Solid Tumors</condition><condition>Cholangiocarcinoma</condition><condition>Hematologic Cancers</condition><disease>Patients With Metastatic Or Unresectable Locally Advanced Malignancies Harboring Specific Genomic Alterations Regarding The Biological Crizotinib Targets, And Who Are No More Amenable To Curative Treatment</disease><disease>Hematologic Neoplasms</disease><disease>Rhabdomyosarcoma</disease><disease>Glioblastoma</disease><disease>Colorectal Cancer</disease><disease>Inflammatory Myofibroblastic Tumour</disease><disease>Neuroblastoma</disease><disease>Breast Cancer</disease><disease>Ovarian Cancer</disease><disease>Thyroid Cancer</disease><disease>Gastric Cancer</disease><disease>Non-small Cell Lung Cancer</disease><disease>Renal Cell Carcinoma</disease><disease>Metastatic Cancer</disease><disease>Liver Carcinoma</disease><disease>Anaplastic Large Cell Lymphoma T- And-cell Types</disease><disease>Solid Tumors</disease><disease>Cholangiocarcinoma</disease><disease>Hematologic Cancers</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2158683</full_dataset_link><location>France</location><study_start_month>8</study_start_month><keyword>Crizotinib</keyword><keyword>Genomic alterations.</keyword><keyword>Biological crizotinib targets (ALK, MET, ROS1, RON, AXL).</keyword><keyword>Metastatic or unresectable locally advanced malignancies.</keyword><repository>ECRIN MDR</repository><study_status>Active, not recruiting</study_status></additional><is_claimable>false</is_claimable><name>Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1</name><description>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.</description><dates><creation>2013-08-15</creation></dates><accession>2158683</accession><cross_references><ClinicalTrials___gov>NCT02034981</ClinicalTrials___gov><EU Clinical Trials Register>2013-000885-13</EU Clinical Trials Register></cross_references></HashMap>