{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2014"],"condition":["Carcinoma, Squamous Cell","Metastatic Colorectal Cancer","Squamous Cell Carcinoma of Head and Neck","Head and neck squamous cell carcinoma.Colorectal cancer.","Squamous Cell Carcinoma of Head and Neck (SCCHN)","Colorectal Neoplasms","Carcinoma escamoso de cabeza y cuello.Cáncer colorrectal metastásico.","Cancer"],"disease":["Carcinoma, Squamous Cell","Head And Neck Squamous Cell Carcinoma.colorectal Cancer.","Metastatic Colorectal Cancer","Squamous Cell Carcinoma Of Head And Neck","Carcinoma Escamoso De Cabeza Y Cuello.cáncer Colorrectal Metastásico.","Squamous Cell Carcinoma Of Head And Neck (scchn)","Colorectal Neoplasms","Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2171726"],"location":["Canada","Netherlands","Belgium","United States","China","Italy","France","Germany","Spain"],"study_start_month":["7"],"keyword":["SCCHN,","Resistance to cetuximab/panitumumab","Squamous cell carcinoma","Rectal cancer","Paranasal sinuses","INC280 200 mg","Lympth nodes of neck","Mucosal lining","Epithelium","Pharynx","Erbitux 5mg/mL","INC280","Parotid glands","C-MET inhibitor","Large intestine","Head and neck","Larynx","Colon","Cetuximab","INC280 50 mg","Oral and nasal cavity"],"repository":["ECRIN MDR"],"study_status":["Terminated"],"additional_accession":[]},"is_claimable":false,"name":"Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy","description":"This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no scheduled break between cycles.\nThe trial was terminated because of difficulties in identifying patients who met the eligibility criteria.","dates":{"creation":"2014-07-15"},"accession":"2171726","cross_references":{"ClinicalTrials___gov":["NCT02205398"],"EU Clinical Trials Register":["2014-000579-20"]}}