UMIN ID: C000000118
Registered date:06/09/2005
A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Non small cell lung cancer |
| Date of first enrollment | 2004/05/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gefinitib daily administration |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 75years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease. |
Related Information
| Primary Sponsor | LOGIK |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | LOGIK |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | LOGIK LOGIK |
| scientific contact | |
| Name | Noriyuki Ebi |
| Address | 3-83 Yoshio-machi, Iizuka city, Fukuoka, Japan Zip-code 820-8505 Japan |
| Telephone | |
| Affiliation | Iizuka Hospital Department of Respiratory Medicine |