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HMPL-813 in Treating Patients With Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03231501
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hutchison Medipharma Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rongjun Liu, M.D.
Principal Investigator Affiliation	Hutchison Medipharma Ltd.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: single arm

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Huashan Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Huashan Hospital

Shanghai, Shanghai, 200031

Site Contact

Xin Zhang, M.D.

[email protected]

+86-13761626836

Hanzhou, Zhejiang, China