HMPL-813 in Treating Patients With Glioblastoma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231501
• Other study ID #: 2016-813-00CH3
• Status: Recruiting
• Phase: Phase 1
• Start date: January 26, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2020
• Source: Hutchison Medipharma Limited
• Contact: Rongjun Liu, M.D.
• Phone: 86-21-2067-3203
• Email: rongjunl[@]hmplglobal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• epitinib succinate
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.

Locations

Country	Name	City	State
China	The second hospital affiliated to Zhejiang University Medical School	Hanzhou	Zhejiang
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (ORR)	the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period	6 months

External Links

•   Sponsor website