GlioblastomaPhase 1NCT03231501
HMPL-813 in Treating Patients With Glioblastoma
A Phase 1 study testing epitinib succinate in people with Glioblastoma, run by Hutchison Medipharma Limited at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- epitinib succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jan 2018to 31 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The second hospital affiliated to Zhejiang University Medical School
Hanzhou, Zhejiang, 310009
Jinfang Xu, M.D., +86-13757118726, xjfxyz@126.com
Chongran Sun, M.D., +86-15925612402, sunchongran@126.com
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200031
Xin Zhang, M.D., +86-13761626836, xinzhanghs@126.com
Wei Hua, M.D., +86-15800589540, hs_glioma@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- epitinib succinate
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epitinib succinateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | This is a single arm study. It is an open-label study. The intervention is eptinib succinate. Receives: Drug: epitinib succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start26 Jan 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, open label study with fixed dose.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rongjun Liu, M.D., Study chair, Hutchison Medipharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231501
- Sponsor's protocol ID
- 2016-813-00CH3
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT03231501
- Acronym / sponsor ID
- 2016-813-00CH3
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, open label study with fixed dose.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: epitinib succinateThis is a single arm study. It is an open-label study. The intervention is eptinib succinate. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epitinib succinateThis 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. | Drug | single arm |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongjun Liu, M.D. study chair
Hutchison Medipharma Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epitinib succinate in people with Glioblastoma, run by Hutchison Medipharma Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongjun Liu, M.D. (86-21-2067-3203, rongjunl@hmplglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.