Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02447419|
Recruitment Status : Unknown
Verified May 2019 by Jeeyun Lee, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : May 18, 2015
Last Update Posted : May 20, 2019
This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
Gefitinib 250 mg will be administered orally daily.
To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||December 3, 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Gefitinib 250 mg will be administered orally daily
Gefitinib 250mg will be administered orally daily
- overall response rate [ Time Frame: up too 100 weeks ]
- progression-free survival [ Time Frame: expected average of 24 weeks ]
- overall survival [ Time Frame: up too 100 weeks ]
- Number of subjects with Adverse Events as a measure of safety [ Time Frame: up too 100 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447419
|Contact: Jee Yun Lee, MD,Ph.D.||2-3410-3459 ext 82|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: yoon Jeong Ahn 221487395 ext 82|
|Principal Investigator: Jeeyun Lee, M.D., Ph.D.|