Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
Status:
Completed
Trial end date:
2017-06-02
Target enrollment:
Participant gender:
Summary
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent
glioblastoma.
3. Exploratory
- To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent
glioblastoma
- To evaluate pharmacodynamic (PD) parameters by clinical biomarker test
Study Methodology
Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next
arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or
other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to
determine the patient's safety with a decision on enrollment into the next arm or change in
dosing frequency of study drug in the above case.
A patient who is withdrawn from the study before the completion of the 1st cycle can be
replaced with another patient. Patients will be treated for up to 1 year, unless a cause for
termination occurs, such as progression of disease (PD) or the withdrawal of consent.