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

NCT02934256 | Completed Phase 2 DMC

• 1 other identifier: Tian-drug-neuro002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Vestibular Schwannoma; Neurofibromatosis Type 2

Keywords

Neurofibromatosis Type 2; Vestibular Schwannoma; Other NF2-related tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline,Month 3,Month 6,Month 9,Month 12

Secondary Outcomes (1)

• Change from Baseline in hearing ability after every course of the treatment

  Baseline,Month 3,Month 6,Month 9,Month 12

Other Outcomes (1)

• Change from baseline in QOL(quality of life) score after every course of the treatment

  Baseline,Month 3,Month 6,Month 9,Month 12

Study Arms (1)

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.

Drug: Icotinib

Interventions

Icotinib DRUG

Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.

Also known as: Icotinib Hydrochloride Tablets

Icotinib，treatment effect evaluation

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Not available for enhanced MRI
• Take part in any other clinical trial
• With other conditions that are considered not suitable for this clinical trial.

Sponsors & Collaborators

• Li Peng: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

Study Sites (2)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, 100050, China

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Neurofibromatosis 2

Interventions

icotinib

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurofibromatoses; Neurofibroma; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pinan Liu

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Fu Zhao

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

CN (2)