Improving Public Cancer Care by Implementing Precision Medicine in Norway
Trial Parameters
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Brief Summary
IMPRESS-Norway is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
Eligibility Criteria
Inclusion Criteria: * Type of Participant and Health status 1. Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated. 2. ECOG performance status 0-2. 3. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome. 4. Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the drug-specific study manuals for each agent will take precedence for this and all inclusion criteria (exceptions for haematological diagnoses): 1. Absolute neutrophil count ≥ 1.5 x109 / L 2. Hemoglobin \> 9 g/dl 3. Platelets \> 75,000/µl 4. Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) 5. AST (SGOT) and ALT(SGPT) \< 2.5 x institutional upper limi