Sentences with phrase «prior active therapy»

A Phase II Single - Arm Trial to Investigate Tepotinib in advanced (Stage IIIB / IV) Non-Small Cell Lung Cancer with MET Exon 14 (METex14) Skipping Alterations After Failure of at Least One Prior Active Therapy, Including a Platinum - Doublet - Containing Regimen

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Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias • Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ≤ 1.5 times ULN) • Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN Exclusion Criteria: • Presence of active / uncontrolled central nervous system involvement • History of clinically significant cardiac disease; uncontrolled hypertension • Left ventricular ejection fraction (LVEF) < 45 % • Allogeneic stem cell transplant within 100 days before first dose of study drug • Known history of human immunodeficiency virus (HIV) infection • Chronic or active hepatitis B or C, requiring antiviral therapy • Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is distinct in primary site or histology from the cancer evaluated in this study • Serious, uncontrolled infection • Unresolved chronic toxicity > grade 1 from prior therapy • Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study
Applicant demonstrates that s / he had at least two (2) years of post-master's or one year of post-doctoral practice in individual and marriage and family therapy under supervision prior to licensure, certification, listing or registration in the jurisdiction through which applicant seeks licensure in Colorado; or applicant provides information satisfactory to the Board demonstrating her / his active practice of marriage and family therapy for two (2) years.
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