UMIN ID: C000000187
Registered date:12/09/2005
A phase II study of gefitinib in PS3 (4) advanced adenocarcinoma of the lung
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | PS 3 patients (or PS 4 patients because of bone or brain metastasis) with advanced adenocarcinoma of the lung. |
| Date of first enrollment | 2003/07/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The treatment schedule included gefitinib at 250mg/day, administered once daily. |
Outcome(s)
| Primary Outcome | Overall response rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with apparent abnormalities on chest X-ray, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, uncontrollable diabetes mellitus, severe infection. |
Related Information
| Primary Sponsor | Department of Medical Oncology, Kinki University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Medical Oncology, Kinki University School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 377-2,Onohigasi,Osakasayama City,Osaka,Jupan Japan |
| Telephone | 072-366-0221 |
| Affiliation | Kinki University School of Medicine Department of Medical Oncology |
| scientific contact | |
| Name | Takayasu Kurata |
| Address | 13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558 Japan |
| Telephone | 078-929-1151 |
| Affiliation | Hyogo Medical Center for Adults Department of Medical Oncology |