HMPL-813 in Treating Patients With Glioblastoma

• Status: Recruiting
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

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