ACTRN12615001156572已完成2 期
A Multicenter, 3-Arm, Open-Label, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients with Recurrent Glioblastoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 19 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Both male and female patients at least 19 years old
- •2. Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
- •3. At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
- •4. Karnofsky Performance Status (KPS) at least 80
- •5. A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
- •a. Hematologic tests
- •Absolute neutrophil count (ANC) at least 1.5 x 109/L
- •Platelets at least 75 x 109/L
- •Hemoglobin at least 9.0 g/dL
- •b. Blood coagulation tests
- •Prothrombin time (PT) at least 1.5 x Upper limit of normal (UNL)
- •Activated partial thromboplastin Time (aPTT) at least 1.5 x UNL
- •c. Hepatic function tests
- •Total bilirubin at least 1.5 x UNL
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at least 3 x ULN
- •d. Renal function test
- •Creatinine clearance (CrCl) at least 30 mL/min
- •7. At least 12 weeks of expected survival time
- •8. Signed informed consent
排除标准
- •1. Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to participating in the study.
- •2. The following concomitant diseases:
- •a. Uncontrolled hypertension (systolic blood pressure [SBP] greater than 150 or diastolic blood pressure [DBP] greater than 90 mmHg)
- •b. Uncontrolled seizures
- •c. Class III or IV heart failure by New York Heart Association (NYHA) classification
- •d. Oxygen-dependent chronic disease
- •e. Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
- •3. Not recovered below National Cancer Institute –Common Terminology for Adverse Events (NCI-CTCAE) grade 2 from AEs due to CCRT
- •4. Treatment with systemic chemotherapy, hormonal therapy, immunotherapy or biologic therapy except CCRT or temozolomide alone within 2 weeks prior to the baseline visit
- •5. Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery)
- •6. Treated with other investigational drugs within 4 weeks prior to the baseline visit for this study
- •7. Pregnant or lactating females, and females/males of childbearing potential who don't agree to a reliable and adequate method of contraception [Hormonal contraceptives such as the combined oral contraceptive pill; intrauterine devices or the implantation of intrauterine system (IUD); blockage methods (condoms, diaphragms, vaginal sponges, cervical cap); sterilization surgery such as tubal ligation in females and vasectomy in males.
- •8. A known history of severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
- •9. Unable to participate in the trial according to the investigator’s decision.
- •10. Previous therapy with vascular endothelial growth factor (VEGF)-targeted agents including (but not limited to) bevacizumab
研究者
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