Vestibular SchwannomaPhase 2IcotinibNCT02934256
Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
A Phase 2 study testing Icotinib in people with Vestibular Schwannoma and Neurofibromatosis Type 2, run by Li Peng at 2 sites in China.
Trial summary
1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Vestibular Schwannoma, Neurofibromatosis Type 2
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2016to Jul 2018
- Phase
- Phase 2
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be at the age of 16-50
- Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
- Patients must not be treated with other drugs or radiation therapy recently
- Patients should live in Beijing or nearby and can be treated in hospital
- Patients must be healthy and not be seriously allergic with biological agents
- Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.
Who cannot join
- Treated with other drugs, surgery or radiation therapy recently
- Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
- Being pregnant or try to get pregnant, lactating women
- With acute or chronic infectious diseases
- With heart diseases, cardiac dysfunction or abnormal ECG
- With uncontrolled neural or mental diseases, poor compliance
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- Not available for enhanced MRI
- Take part in any other clinical trial
- With other conditions that are considered not suitable for this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100050
About this study
Official title: Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.
Read the detailed description
Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.
Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in tumor size.
Much evidence implicates human epidermal growth factor (HER) receptors in vestibular schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product, controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures. This effect appears to be mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2.
- Conditions
- Vestibular Schwannoma, Neurofibromatosis Type 2
- Being tested
- Icotinib
- Keywords
- Neurofibromatosis Type 2, Vestibular Schwannoma, Other NF2-related tumors
- Medical subject headings
- Neuroma, Acoustic, Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Icotinib Hydrochloride Tablets
Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib，treatment effect evaluation | Experimental | Patients use Icotinib hydrochloride tablets during the course of treatment. The drug dosage is 125mg/m3/d. Every course of treatment lasts three months. Patients are designed to receive total four courses of treatment if there is no disease progression. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in volume of tumour after every course of the treatment
Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
Measured: Baseline,Month 3,Month 6,Month 9,Month 12
Secondary outcomes (1)
Change from Baseline in hearing ability after every course of the treatment
Patients' hearing ability would be tested after every course of the treatment.
Measured: Baseline,Month 3,Month 6,Month 9,Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor-investigator, Li Peng, Beijing Tiantan Hospital
- Investigators
- Pinan Liu, Study director, Beijing Tiantan HospitalFu Zhao, Principal investigator, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934256
- Sponsor's protocol ID
- Tian-drug-neuro002
- Acronym
- Icotinib
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2016
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
- ClinicalTrials.gov ID
- NCT02934256
- Acronym / sponsor ID
- Icotinib / Tian-drug-neuro002
- Conditions
- Vestibular Schwannoma, Neurofibromatosis Type 2
- Keywords
- Neurofibromatosis Type 2, Vestibular Schwannoma, Other NF2-related tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Li PengUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.
Detailed description
Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.
Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in tumor size.
Much evidence implicates human epidermal growth factor (HER) receptors in vestibular schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product, controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures. This effect appears to be mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib，treatment effect evaluation | Experimental | Drug: IcotinibPatients use Icotinib hydrochloride tablets during the course of treatment. The drug dosage is 125mg/m3/d. Every course of treatment lasts three months. Patients are designed to receive total four courses of treatment if there is no disease progression. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients must be at the age of 16-50
- Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
- Patients must not be treated with other drugs or radiation therapy recently
- Patients should live in Beijing or nearby and can be treated in hospital
- Patients must be healthy and not be seriously allergic with biological agents
Key exclusion criteria (9 listed)
- Treated with other drugs, surgery or radiation therapy recently
- Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
- Being pregnant or try to get pregnant, lactating women
- With acute or chronic infectious diseases
- With heart diseases, cardiac dysfunction or abnormal ECG
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 |
|---|---|---|
| IcotinibAlso: Icotinib Hydrochloride TabletsMethod of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses. | Drug | Icotinib，treatment effect evaluation |
Primary outcome
Change from Baseline in volume of tumour after every course of the treatment
Time frame: Baseline,Month 3,Month 6,Month 9,Month 12
Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
1 secondary outcome
Change from Baseline in hearing ability after every course of the treatment
Time frame: Baseline,Month 3,Month 6,Month 9,Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Pinan Liu study director
Beijing Tiantan Hospital
Fu Zhao principal investigator
Beijing Neurosurgical Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib in people with Vestibular Schwannoma and Neurofibromatosis Type 2, run by Li Peng 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 9 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in volume of tumour after every course of the treatment (time frame: Baseline,Month 3,Month 6,Month 9,Month 12). 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 9 Sep 2021.