HMPL-813 in Treating Patients With Glioblastoma

A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma

This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.

Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.

Inclusion Criteria:

1. Histologically confirmed glioblastoma
2. Standard treatment failed or no standard treatment
3. EGFR gene amplification
4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
5. Age ≥ 18
6. Eastern Cooperative Oncology Group (ECOG) score ≤2

Exclusion Criteria:

1. Use of Antiepileptic drugs were used] within 2 weeks before enrollment
2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment
3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery
4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
5. Eye disease or dry eye syndrome history
6. Positive pregnancy tested result