Back to resultsHMPL-813 in Treating Patients With Glioblastoma
Primary Purpose
Glioblastoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
epitinib succinate
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Huashan HospitalRecruiting
- The second hospital affiliated to Zhejiang University Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
Outcomes
Primary Outcome Measures
objective response rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Secondary Outcome Measures
Full Information
NCT ID
NCT03231501
First Posted
July 19, 2017
Last Updated
June 12, 2020
Sponsor
Hutchison Medipharma Limited
1. Study Identification
Unique Protocol Identification Number
NCT03231501
Brief Title
HMPL-813 in Treating Patients With Glioblastoma
Official Title
A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm, open label study with fixed dose.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
Intervention Type
Drug
Intervention Name(s)
epitinib succinate
Intervention Description
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.
Primary Outcome Measure Information:
Title
objective response rate (ORR)
Description
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongjun Liu, M.D.
Phone
86-21-2067-3203
Email
rongjunl@hmplglobal.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wu, M.D.
Phone
86-21-2067-3000
Ext
5830
Email
yanwu@hmplglobal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongjun Liu, M.D.
Organizational Affiliation
Hutchison Medipharma Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhang, M.D.
Phone
+86-13761626836
Email
xinzhanghs@126.com
First Name & Middle Initial & Last Name & Degree
Wei Hua, M.D.
Phone
+86-15800589540
Email
hs_glioma@126.com
First Name & Middle Initial & Last Name & Degree
Ying MAO, PhD
Facility Name
The second hospital affiliated to Zhejiang University Medical School
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinfang Xu, M.D.
Phone
+86-13757118726
Email
xjfxyz@126.com
First Name & Middle Initial & Last Name & Degree
Chongran Sun, M.D.
Phone
+86-15925612402
Email
sunchongran@126.com
First Name & Middle Initial & Last Name & Degree
Jianmin Zhang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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HMPL-813 in Treating Patients With Glioblastoma
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