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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01312337
Other study ID # 2010-07-252
Secondary ID
Status Recruiting
Phase Phase 2
First received February 21, 2011
Last updated March 8, 2011
Start date September 2010

Study information

Verified date March 2011
Source Samsung Medical Center
Contact Myung-Ju Ahn, Pf
Phone 82-2-3410-3459
Email silkahn@skku.edu
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pathologically proven NSCLC

- Ineligibile for curative treatment (namely, stage IIIb or IV)

- History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)

- At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)

- 18 years old or older

- Performance status ECOG 0-2

- Adequate organ function as evidenced by the following:

- Absolute neutrophil count > 1.0 x 109/L

- Platelets > 75 x 109/L

- Total bilirubin = 1.5 UNL

- AST and/or ALT < 5 UNL

- Creatinine clearance = 45mL/min

Exclusion Criteria:

- Previous EGFR TKI therapy history

- Systemic anticancer therapy within the previous 3 weeks

- Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer

- Other concurrent illness that would preclude study participation (severe heart disease)

- Other concurrent physical condition (e.g., infectious disease) that would preclude study participation

- Pregnant or nursing

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
salvage iressa
Iressa 250mg per day until progression

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine disease control rate at 8 weeks will be 35% or higher in the the study group 6 months after the enrollment of the last patients No
Secondary The number of patients who live longer than 6 months after enrollment 6 months after the enrollment of the last patients No
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