Overview

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

Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Li Peng
Collaborators:
Betta Pharmaceuticals Co., Ltd.
Betta Pharmaceuticals Co.,Ltd.
Criteria
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.