HMPL-813 in Treating Patients With Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-26

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm, open label study with fixed dose.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

This is a single arm study. It is an open-label study. The intervention is eptinib succinate.

Group Type EXPERIMENTAL

epitinib succinate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No