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Carolina","29425",{"type":44,"coordinates":106},[107,108],-79.93275,32.77632,{"lat":108,"lon":107},{"facility":11,"status":11,"city":111,"state":112,"zip":113,"country":41,"countryCode":42,"cosmosGeoPoint":114,"geoPoint":118,"contacts":11},"Nashville","Tennessee","37232",{"type":44,"coordinates":115},[116,117],-86.78444,36.16589,{"lat":117,"lon":116},{"facility":11,"status":11,"city":120,"state":121,"zip":122,"country":41,"countryCode":42,"cosmosGeoPoint":123,"geoPoint":127,"contacts":11},"Dallas","Texas","75246",{"type":44,"coordinates":124},[125,126],-96.80667,32.78306,{"lat":126,"lon":125},{"type":129,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100153066","phase-1-a-study-of-the-effect-of-food-on-the-pharmacokinetics-of-single-dose-ro5185426-and-the-safety-and-efficacy-of-continuous-administration-in-patients-with-braf-v600e-mutation-positive-metastatic-melanoma-100153066",true,"NCT01264380","A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma","A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients","Inclusion Criteria:\n\n* Adult patients, \\>\u002F= 18 years of age\n* Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)\n* Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test\n* Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be \\>\u002F= 28 days; patients must have recovered fully from toxicities of all prior therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Evaluable disease (measurable for disease progression according to RECIST criteria)\n* Adequate hematological, renal and liver function\n\nExclusion Criteria:\n\n* Active CNS lesions\n* History of or known spinal cord compression or carcinomatous meningitis\n* Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study\n* Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix\n* Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor\n* Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug",false,"ALL","18 Years",{"count":141,"type":142},16,"ACTUAL","INTERVENTIONAL",[145],"PHASE1","This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.",[148],"Malignant Melanoma","COMPLETED","2016-11-01",{"date":152,"type":153},"2016-11-02","ESTIMATED",{"date":155,"type":11},"2011-01",{"date":157,"type":142},"2013-05",{"name":5,"class":6},10]