{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2013"],"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","Liver carcinoma","Hematologic Neoplasms","Rhabdomyosarcoma","Glioblastoma","Colorectal cancer","Breast cancer","Neuroblastoma","Ovarian cancer","Thyroid cancer","Renal cell carcinoma","Non-small cell lung cancer","Anaplastic large cell lymphoma T- and-cell types","Inflammatory myofibroblastic tumour","Metastatic Cancer","Gastric cancer","Solid Tumors","Cholangiocarcinoma","Hematologic Cancers"],"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","Hematologic Neoplasms","Rhabdomyosarcoma","Glioblastoma","Colorectal Cancer","Inflammatory Myofibroblastic Tumour","Neuroblastoma","Breast Cancer","Ovarian Cancer","Thyroid Cancer","Gastric Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Metastatic Cancer","Liver Carcinoma","Anaplastic Large Cell Lymphoma T- And-cell Types","Solid Tumors","Cholangiocarcinoma","Hematologic Cancers"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2158683"],"location":["France"],"study_start_month":["8"],"keyword":["Crizotinib","Genomic alterations.","Biological crizotinib targets (ALK, MET, ROS1, RON, AXL).","Metastatic or unresectable locally advanced malignancies."],"repository":["ECRIN MDR"],"study_status":["Active, not recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1","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).\nFor 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.","dates":{"creation":"2013-08-15"},"accession":"2158683","cross_references":{"ClinicalTrials___gov":["NCT02034981"],"EU Clinical Trials Register":["2013-000885-13"]}}