Status:
UNKNOWN
HMPL-813 in Treating Patients With Glioblastoma
Lead Sponsor:
Hutchison Medipharma Limited
Conditions:
Glioblastoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 amplificat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed glioblastoma
- Standard treatment failed or no standard treatment
- EGFR gene amplification
- Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) score ≤2
Exclusion
- Use of Antiepileptic drugs were used\] within 2 weeks before enrollment
- 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
- 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
- Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
- Eye disease or dry eye syndrome history
- Positive pregnancy tested result
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03231501
Start Date
January 26 2018
End Date
August 31 2020
Last Update
June 16 2020
Active Locations (2)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200031
2
The second hospital affiliated to Zhejiang University Medical School
Hanzhou, Zhejiang, China, 310009