NCT00344773

Brief Summary

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 4, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

June 26, 2006

Results QC Date

December 19, 2008

Last Update Submit

June 24, 2010

Conditions

Pulmonary Cancer

Keywords

Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutationMetastatic (IV) pulmonary adenocarcinoma with EGFR mutationRecurrent pulmonary adenocarcinoma with EGFR mutation

Outcome Measures

Primary Outcomes (1)

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

    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

    baseline to 12 months

Secondary Outcomes (3)

  • Progression Free Survival (PFS)

    baseline to 4 months

  • Overall Survival (OS)

    baseline to 12 months

  • Safety Profile: Participants With Adverse Events

    baseline to end of study

Study Arms (1)

Gefitinib

EXPERIMENTAL

Gefitinib 250mg tablet once daily

Drug: Gefitinib

Interventions

GefitinibDRUG

250mg tablet oral tablet once daily

Also known as: ZD1839, IRESSA
Gefitinib

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Seongnam-si, South Korea

Location

Research Site

Seoul, South Korea

Location

Related Publications (1)

  • Kim DW, Lee SH, Lee JS, Lee MA, Kang JH, Kim SY, Shin SW, Kim HK, Heo DS. A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. Lung Cancer. 2011 Jan;71(1):65-9. doi: 10.1016/j.lungcan.2010.04.005.

    PMID: 20430469DERIVED

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm Metastasis

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
Astrazeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • HyeJong Yoo

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 29, 2010

Results First Posted

June 4, 2010

Record last verified: 2010-06

Locations

KR(2)