- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824746
Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC) (ReGaiN)
January 22, 2013 updated by: Young-Chul Kim, Chonnam National University Hospital
Retreatment of Gefitinib in the Patients With Non-small Cell Lung Cancer (NSCLC) Previously Responded to Gefitinib A Single Arm, Open Label, Phase II Study
A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure.
Primary endpoint
- to assess Disease Control Rate (Remission + Stable disease)
Secondary endpoints
- to assess the progression free survival
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jeonnam
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Hwasun-gun, Jeonnam, Korea, Republic of, 519-809
- Chonnam National University Hwasun Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) stage IV or IIIB patients after chemotherapy following gefitinib failure
- Male and female patients aged over 18 years
- World Health Organization (WHO) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- Had at least stable disease with previous Gefitinib treatment
- Had at least one anticancer agent therapy after gefitinib failure ;Following treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)- erlotinib or other TKIs should not be included in anticancer agent therapy.
- The current approved indication of Gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic NSCLC. However, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. Thus, in this trial gefitinib retreatment will be 3rd line or more.
- Measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- Provision of written informed consent
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Expected life expectancy less than 2 months
- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Any unresolved chronic toxicity greater that Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x Upper Limit Normal (ULN) if no demonstrable liver metastases (or >5 x in presence of liver metastases)
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
- Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gefitinib retreatment group
Gefitinib retreatment
|
phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT
Time Frame: 8 weeks
|
Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 2 years
|
2 years
|
|
Progression - Free Survival of Patients Retreated With Gefitinib
Time Frame: two year
|
Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.
|
two year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 16, 2009
First Submitted That Met QC Criteria
January 16, 2009
First Posted (Estimate)
January 19, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2013
Last Update Submitted That Met QC Criteria
January 22, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- D791JL00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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