CTRI/2017/09/009954招募中4 期
An open label, non- randomized, single dose, parallel bioequivalence study oftwo formulations of Erlotinib (Innovator- Tarceva and Generic- Tyrokinin) or Gefitinib(Innovator- Iressa and Generic- Xefta) in adult non-small cell lung cancer (NSCLC) patientswith non- squamous histology who have undergone atleast one previous chemotherapy.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients on erlotinib/gefitinib for advanced/metastatic non-squamous NSCLC
- •2.Patient should have received chemotherapy with taxanes or pemetrexed with platinum
- •3. ECOg equal to or less than 2
排除标准
- •1.Cancer spread to bowel
- •2.Females who are lactating, pregnant or planning to become pregnant
- •3.Consumption of alcohol/ smoking in last 7 days
- •4.h/o allergy to study medications
- •5.h/o pyloric obstruction
- •6. any other medical condition or abnormal screening, abnormal lab findings which may affect study data as per PI discretion
- •7. patient has undergone prior sx, radiation, chemo, other anti-cancer therapy within 5 t1/2 prior to dosing
- •8. patient with known HIV, Hep B positive, HAV and HCV antibody
- •9. Donation of blood within 90 days prior
- •10. Any other condition which may affect PK of drugs
- •11. Any drug affecting absorption of erlotinib, gefitinib
研究者
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