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An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.


Phase 2
19 Years
N/A
Not Enrolling
Both
Pulmonary Cancer

Thank you

Trial Information

An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.


Inclusion Criteria:



- Patients require histological biopsy and paraffin block more than 5mg from the
original tumour or metastatic site to perform EGFR mutational analysis

- WHO Performance Status 0-2

- No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

- Any evidence of clinically active interstitial lung disease

- Newly diagnosed CNS metastases that have not yet been definitively treated with
surgery /radiation

- Patients with previously diagnosed and treated CNS metastases or spinal cord
compression

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

Outcome Description:

Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Outcome Time Frame:

baseline to 12 months

Safety Issue:

No

Principal Investigator

HyeJong Yoo

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Korea: Food and Drug Administration

Study ID:

D7913L00056

NCT ID:

NCT00344773

Start Date:

March 2006

Completion Date:

December 2007

Related Keywords:

  • Pulmonary Cancer
  • Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation
  • Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation
  • Recurrent pulmonary adenocarcinoma with EGFR mutation
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms

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