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
1 other identifier
interventional
29
1 country
2
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 amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2018
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJune 16, 2020
June 1, 2020
2.4 years
July 19, 2017
June 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
objective response rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
6 months
Study Arms (1)
single arm
EXPERIMENTALThis is a single arm study. It is an open-label study. The intervention is eptinib succinate.
Interventions
This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Huashan Hospital
Shanghai, Shanghai Municipality, 200031, China
The second hospital affiliated to Zhejiang University Medical School
Hanzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rongjun Liu, M.D.
Hutchison Medipharma Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2017
First Posted
July 27, 2017
Study Start
January 26, 2018
Primary Completion
June 30, 2020
Study Completion
August 31, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share