HMPL-813 in Treating Patients With Glioblastoma

June 12, 2020 updated by: Hutchison Medipharma Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Huashan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ying MAO, PhD
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • Recruiting
        • The second hospital affiliated to Zhejiang University Medical School
        • Contact:
          • Jinfang Xu, M.D.
          • Phone Number: +86-13757118726
          • Email: xjfxyz@126.com
        • Contact:
        • Principal Investigator:
          • Jianmin Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: 6 months
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchison Medipharma Limited

Investigators

  • Study Chair: Rongjun Liu, M.D., Hutchison Medipharma Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2018

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-813-00CH3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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