Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors
- Conditions
- Solid tumor
- Registration Number
- JPRN-UMIN000008336
- Lead Sponsor
- OncoTherapy Science, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1)symptomatic brain metastasis 2)pleural effusion, ascites fluid, pericardial fluid requiring drenege 3)Unhealed traumatic lesion 4)Hemorrhagic diathesis or severe coagulopthy, and patients with those histories 5)hemoptysis or lung hemorrhage or gastrointestinal bleeding, and patients with those histories 6)uncontrolled hypertension (systolic:140 mmHg and over, diastolic: 90 mmHg and over), or serious arrhythmia or heart failure 7)serious complication, equivalent to CTCAE grade 3 or greater 8)Patients who require systemic administration of the following agents during OTS102 study medication period. -Corticosteroid, Anticoagulant drug, Immunosuppresant, Immunostimulant -Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte, Macrophage Colony Stimulating Factor (GM-CSF), Erythropoietin (EPO) 9)Participating in drug clinical trials 10)Woman who is pregnant, breast feeding and child-bearing potential. 11)Patient or patient's partner unwilling to use adequate contraception. 12)As determined by the principal investigator or the sub-investigator the subject has difficulties that would prevent the subject's ability to participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of adverse event and Dose-Limiting Toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Efficacy (Tumor resuponse assessment based on the Response Evaluation Criteria in Solid Tumor [RECIST] guidelines)