UMIN ID: C000000151
Registered date:09/09/2005
Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | non-small cell lung cancer |
| Date of first enrollment | 2005/03/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | gefitinib 250mg/m2 /day orally |
Outcome(s)
| Primary Outcome | (Primary Endpoint) Response rate |
|---|---|
| Secondary Outcome | (Secondary Endpoint) Overall survival, One year survival, Time to progression, disease control rate, safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Intestinal pneumonia or lung fibrosis 2) History of severe drug allergic reaction 3) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 4) Severe diarrhea 5) Bowel obstruction,ileus 6) Symptomatic brain metastasis 7) History of other malignancy 8) Pregnant women or women willing child-bearing 9) No regulatory condition because of psychological disease 10) Inadequate condition diagnosed by primary physician |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Kenji Tamura MD |
| Address | 1248-1, Otoda, Ikoma, Nara, 630-0293, Japan Japan |
| Telephone | 0743-77-0880 |
| Affiliation | Kinki University School of Medicine, Nara Hospital Department of Medical Oncology |