None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety and efficacy of tanibirumab in participants with recurrent glioblastoma multiforme (GBM). Who is it for? You may be eligible to join this study if you are aged 19 or over, and have been diagnosed with recurrent GBM following treatment with temozolomide chemotherapy with radiotherapy. Study details Tumour angiogenesis is the process that leads to the formation of blood vessels in a tumour, which in turn support cancer cell survival, local tumour growth, and the development of distant metastasis. The investigational drug tanibirumab (TTAC-0001) interferes with the angiogenesis process, inhibiting the formation of the blood vessels and thereby starving the tumour cells of the nutrients and oxygen required for growth. Participants in this study will be enrolled sequentially to arm 1, 2 or 3 with participants enrolled to arm 2 and 3 only after a safety evaluation of the previous arm. Each patient will only be allocated to one arm depending on the time of enrolment. All participants will receive tanibirumab in 3 or 4 doses, one per week, per cycle, for a total of up to 1 year, disease progression or study withdrawal. Throughout the study safety will be assessed by monitoring and assessment of adverse events, vital signs, laboratory tests including testing for immunogenicity (the ability of the study drug to provoke an immune response). Tumour response will be assessed by evaluating MRI scans performed every 8 weeks during treatment and at treatment termination. Blood sampling for drug interaction and distribution within the body will also be collected. It is hoped that the findings of this trial will develop our understanding of the safety of tanibirumab and of it's efficacy as a potential drug treatment for recurrent glioblastoma.
Interventions
3 treatment arms:
Arm 1 - (tanibirumab 8 mg/kg days 1, 8, 15 /4 weeks): 1 intravenous infusion/week, 3 infusions per cycle and 1 week observation. Treatment period: maximum one year
Arm 2 - (tanibirumab 12mg/kg days 1, 8, 15 /4 weeks): 1 intravenous infusion/week, 3 infusions per cycle and 1 week observation. Treatment period: maximum one year
Arm 3 - (tanibirumab 12mg/kg weekly): 1 intravenous infusion/week, 4 infusions per cycle and no observation period. Treatment period: maximum one year
A
3 treatment arms: Arm 1 - (tanibirumab 8 mg/kg days 1, 8, 15 /4 weeks): 1 intravenous infusion/week, 3 infusions per cycle and 1 week observation. Treatment period: maximum one year Arm 2 - (tanibirumab 12mg/kg days 1, 8, 15 /4 weeks): 1 intravenous infusion/week, 3 infusions per cycle and 1 week observation. Treatment period: maximum one year Arm 3 - (tanibirumab 12mg/kg weekly): 1 intravenous infusion/week, 4 infusions per cycle and no observation period. Treatment period: maximum one year All doses will be administered at study sites.
Sponsors
PharmAbcine Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed