A study to understand if different brands of the drugs Erlotinib or Gefitinib used in lung cancer give the same concentration in blood of patients and whether they can be used interchangeably.
- Conditions
- Health Condition 1: C340- Malignant neoplasm of main bronchus
- Registration Number
- CTRI/2017/09/009954
- Lead Sponsor
- DR REDDYS LABORATORIES LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method