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.

An open label, non- randomized, single dose, parallel bioequivalence study of two formulations of Erlotinib (Innovator- Tarceva and Generic- Tyrokinin) or Gefitinib (Innovator- Iressa and Generic- Xefta) in adult non-small cell lung cancer (NSCLC) patients with non- squamous histology who have undergone atleast one previous chemotherapy.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009954

Enrollment

180

Registered

2017-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C340- Malignant neoplasm of main bronchus

Interventions

Intervention1: Erlotinib - Tarceva Gefitinib- Iressa: Single dose of Tab Erlotinib -150 mg given orally Single dose of Tab Gefitinib -250 mg given orally Control Intervention1: Erlotinib - Tyrokinin

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Bioequivalence of Erlotinib/ Gefitinib relativeto reference productTimepoint: At the end of 1st dose ( post 72 hr PK sampling)	—

Secondary

Measure	Time frame
Safety of generic formulation vs reference productTimepoint: At the end of 1 month of therapy.	—

Countries

India

Contacts

Public ContactDr Vikram Gota

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), TMC

vgota@actrec.gov.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026