Open Label Study to Evaluate tanibirumab (TTAC-001) in Patients with Recurrent Glioblastoma
- Conditions
- GlioblastomaCancer - Brain
- Registration Number
- ACTRN12615001156572
- Lead Sponsor
- PharmAbcine Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method