<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2014</study_start_year><condition>Carcinoma, Squamous Cell</condition><condition>Metastatic Colorectal Cancer</condition><condition>Squamous Cell Carcinoma of Head and Neck</condition><condition>Head and neck squamous cell carcinoma.Colorectal cancer.</condition><condition>Squamous Cell Carcinoma of Head and Neck (SCCHN)</condition><condition>Colorectal Neoplasms</condition><condition>Carcinoma escamoso de cabeza y cuello.Cáncer colorrectal metastásico.</condition><condition>Cancer</condition><disease>Carcinoma, Squamous Cell</disease><disease>Head And Neck Squamous Cell Carcinoma.colorectal Cancer.</disease><disease>Metastatic Colorectal Cancer</disease><disease>Squamous Cell Carcinoma Of Head And Neck</disease><disease>Carcinoma Escamoso De Cabeza Y Cuello.cáncer Colorrectal Metastásico.</disease><disease>Squamous Cell Carcinoma Of Head And Neck (scchn)</disease><disease>Colorectal Neoplasms</disease><disease>Cancer</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2171726</full_dataset_link><location>Canada</location><location>Netherlands</location><location>Belgium</location><location>United States</location><location>China</location><location>Italy</location><location>France</location><location>Germany</location><location>Spain</location><study_start_month>7</study_start_month><keyword>SCCHN,</keyword><keyword>Resistance to cetuximab/panitumumab</keyword><keyword>Squamous cell carcinoma</keyword><keyword>Rectal cancer</keyword><keyword>Paranasal sinuses</keyword><keyword>INC280 200 mg</keyword><keyword>Lympth nodes of neck</keyword><keyword>Mucosal lining</keyword><keyword>Epithelium</keyword><keyword>Pharynx</keyword><keyword>Erbitux 5mg/mL</keyword><keyword>INC280</keyword><keyword>Parotid glands</keyword><keyword>C-MET inhibitor</keyword><keyword>Large intestine</keyword><keyword>Head and neck</keyword><keyword>Larynx</keyword><keyword>Colon</keyword><keyword>Cetuximab</keyword><keyword>INC280 50 mg</keyword><keyword>Oral and nasal cavity</keyword><repository>ECRIN MDR</repository><study_status>Terminated</study_status></additional><is_claimable>false</is_claimable><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</name><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.
The trial was terminated because of difficulties in identifying patients who met the eligibility criteria.</description><dates><creation>2014-07-15</creation></dates><accession>2171726</accession><cross_references><ClinicalTrials___gov>NCT02205398</ClinicalTrials___gov><EU Clinical Trials Register>2014-000579-20</EU Clinical Trials Register></cross_references></HashMap>