None small cell lung cancer
Conditions
Interventions
200mg:oral dosing icotinib, bid, in continuing 28 days, to assess safety via collecting blood and urine sample pre-dosing at day1, day11, day18, day25, day31. to assess pharmacokinetics via collecting
150mg:oral dosing icotinib, bid, in continuing 28 days, to assess safety via collecting blood and urine sample pre-dosing at day1, day11, day18, day25, day31. To assess pharmacokinetics via collecting
Sponsors
Zhejiang Beta Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of lung cancer; present with locally advanced (Stage IIIA or IIIB), stage IV or relapse?metastatic and patients with tumour; 2. Patients have received chemotherapy of cytotoxic drug, and prior chemotherapy must be completed at least 3-4 weeks before been enrolled in the study. Patients must have recovered from the any toxic effects of the treatment prior to be enrolled in the study; 3. Patients with at least one measurable lesion meeting RECIST: At least one measurable lesion. Histology and/or cytology diagnosis will be necessary if patients with only one lesion; 4. ECOG Performance Status of 0,1; and behaviour condition integration(PS)<=1; 5. Life expectancy of at least 12 weeks; 6. 18 years of age or older; 7. Adequate organ function, meeting the following; 8. Female: those who with childbearing potential must have a negative pregnancy test performed within 72 hours prior to treatment, Or must use an approved contraceptive method during and for 3 months after the study; must have a negative serum or urine pregnancy test, and must not be breast-feeding; 9. Male: must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment; 10. Patients compliance and geographic proximity that allow adequate follow-up; 11. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Have received HER/EGFR inhibitor and other molecular target drugs (micromolecular drug or MoAb) in other study, including endostar, Avastin, Iressa, Tarceva, Sutent, Nexavar, Sprycel, Erbitux and Herceptin; 2. Have a known hypersensitivity to icotinib or any of the excipient of icotinib; 3. concurrent treatment with sodium phenytoin, carbamazepine, rifampin, barbital or Sant Jone grass; 4. Have received treatment within the last 30 days with other study drug or a drug that has not received regulatory approval for any indication at the time of study entry; 5. Organ or system status; 6. Inadequate organ function including the following: 7. Have previously registration or withdrawn from this study; 8. Life expectancy no more than 12 weeks; 9. Participate the plan and management of research(refer to the employees of beta pharmaceutical limited company or study institution people; 10. Concurrent administration of any other antitumor therapy; 11. Pregnant or breast- feeding; 12. Inability to comply with protocol or study procedures in the opinion of the investigator(management or any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Tolerance;Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| QLQ rating and preliminary observation of curative effect; | — |
Countries
China
Contacts
Public ContactZhang Li
Outcome results
None listed