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This study examined the combined use of the drugs Trametinib and Panitumumab in patients with RAS/RAF wild-type (non-mutated) advanced colorectal cancer. It included patients aged 18 and over with KRAS/NRAS/BRAF wild-type disease not responsive to standard therapies. It was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 18 years of age or older * KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy * Prior 5-FU, oxaliplatin and irinotecan * ECOG Performance Status of 0 or 1 * Able to swallow/retain oral drugs * Able and agree to have provide tumor tissue/have biopsies * Agree to use contraception * Not pregnant * Adequate organ system function Exclusion Criteria: * Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies \<28 days or 5 half lives * Prior EGFR, MEK, or RAF inhibitor or regorafenib * Current use of prohibited medications * Unresolved side effects * GI disease or other condition affecting GI absorption * Mucosal or internal bleeding * Any major surgery \<four weeks * HIV, HBV, or HCV positive * Active infection * Leptomeningeal disease * Brain metastases * Unacceptable QTcF interval * Significant uncontrolled arrhythmias * Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting \< 6 mos. * Class II, III, or IV heart failure * Other clinically significant ECGs * Intra - cardiac defibrillators * Cardiac metastases * Condition that may interfere with patient safety * Hypersensitivity to study drugs * Severe or uncontrolled systemic diseases * Pregnant or lactating * Retinal vein occlusion * Interstitial lung disease or pneumonitis * Active liver or biliary disease