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Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors (Icotinib)

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ClinicalTrials.gov Identifier: NCT02934256
Recruitment Status : Unknown
Verified February 2017 by Li Peng, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : October 14, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Betta Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Li Peng, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE October 13, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date February 9, 2017
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02934256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
Change from Baseline in hearing ability after every course of the treatment [ Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12 ]
Patients' hearing ability would be tested after every course of the treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 13, 2016)
Change from baseline in QOL(quality of life) score after every course of the treatment [ Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12 ]
Patients' QOL(quality of life) would be evaluated after every course of the treatment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Official Title  ICMJE Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Schwannoma
  • Neurofibromatosis Type 2
Intervention  ICMJE Drug: Icotinib
Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
Other Name: Icotinib Hydrochloride Tablets
Study Arms  ICMJE Experimental: Icotinib,treatment effect evaluation
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.
Intervention: Drug: Icotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 13, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must be at the age of 16-50
  2. Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
  3. Patients must not be treated with other drugs or radiation therapy recently
  4. Patients should live in Beijing or nearby and can be treated in hospital
  5. Patients must be healthy and not be seriously allergic with biological agents
  6. Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.

Exclusion Criteria:

  1. Treated with other drugs, surgery or radiation therapy recently
  2. Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
  3. Being pregnant or try to get pregnant, lactating women
  4. With acute or chronic infectious diseases
  5. With heart diseases, cardiac dysfunction or abnormal ECG
  6. With uncontrolled neural or mental diseases, poor compliance
  7. Not available for enhanced MRI
  8. Take part in any other clinical trial
  9. With other conditions that are considered not suitable for this clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02934256
Other Study ID Numbers  ICMJE Tian-drug-neuro002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Li Peng, Beijing Tiantan Hospital
Study Sponsor  ICMJE Li Peng
Collaborators  ICMJE Betta Pharmaceuticals Co., Ltd.
Investigators  ICMJE
Study Director: Pinan Liu Beijing Tiantan Hospital
Principal Investigator: Fu Zhao Beijing Neurosurgical Institute
PRS Account Beijing Tiantan Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP