Solid Tumors
Conditions
Interventions
OTS11101 1.0mg/mL will be administered by subjection once a week. When the recommended dose is decided by [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], administering the recomme
Sponsors
Oncotherapy science,Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], patients who completed the end of clinical inspection without drop out. (2) After [Phase1 Study of OTS11101 in Patients with Solid Cancer], patients wish to continue to use of OTS11101, there is no obvious underlying disease progression, and there is the clinical benefit in patients by continued use of OTS11101 were judged by the investigator or subinvestigator. (3) ECOG Performance Status must be 0 to 2. (4) Patients who are free of marked failure of major organ function, more over the following criteria must be satisfied in laboratory tests. 1. Hematopoietic function White blood cell count: >=3000/mm3, <=12000/mm3 Hemoglobin: >=9g/dl Platelet count: >=100000/mm3 (G-CSF, Erythropoetin, Blood products and transfusion must be untried within 2 weeks days before registration.) 2. Hepatic function AST and ALT: <=2.5*Upper Limit of Normal(ULN),<=5.0*ULN in case of patients have metastasis in the liver. Total bilirubin:<=1.5*ULN 3. Renal function Cre: <=1.5*ULN (5) Patients who hope for continued administration of investigational new drug by patients themselves, and an agreement for this clinical trial participation is provided by a document.
Exclusion criteria
Exclusion criteria: (1) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], patients who experienced serious adverse events not to be denied the causal relationship between OTS11101. (2) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], Patients showed a obvious progression of the underlying disease. (3) Symptomatic brain metastasis. (4) Pleural effusion, ascites fluid, pericardial fluid requiring drainage. (5) Unhealed traumatic lesion, including traumatic fracture. (6) History of clinically important bleeding. (7) 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. (8) Uncontrolled hypertension (Systolic pressure>=140mmHg, Diastolic pressure>=90mmHg), serious arrhythmia or cardiac failure. (9) Other serious complication. (10) 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 (11) Patients who are participating in clinical trials except [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors]. (12) Woman who is pregnant, breast feeding and child-bearing potential. (13) 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. (14) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse event. | — |
Countries
Japan
Outcome results
None listed