Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors - Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors

Oncotherapy science,Inc.0 个研究点目标入组 18 人开始时间: 2009年11月4日最近更新: 2023年10月17日

适应症

试验速览

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•(1) Symptomatic brain metastasis. (2) Pleural effusion, ascites fluid, pericardial fluid requiring drainage. (3) Unhealed traumatic lesion, including traumatic fracture. (4) History of clinically important bleeding. (5) History of myocardial infarction, severe unstable angine pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OTS11101. (6) Uncontrolled hypertension (Systolic pressure>=140mmHg, Diastolic pressure>=90mmHg), serious arrhythmia or cardiac failure. (7) Other serious complication. (8) Patients who require systemic administration of the following agents during the study treatment period. 1. Corticosteroid 2. Anticoagulant 3. Immunosuppresant, Immunostimulant 4. G-CSF 5. Erythropoietin (9) Current participation in other drug clinical trials. (10) Woman who is pregnant, breast feeding and child-bearing potential. (11) Patient or patients partner unwilling to use adequate contraception during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female. (12) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.

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