UMIN ID: C000000141
Registered date:08/09/2005
A phase II study of Amrubicin in patients with previously treated small cell lung cancer
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | small cell lung cancer |
| Date of first enrollment | 2005/12/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Amrubicin 40 mg/m2 on days 1, repeated every 21 days. |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Pregnancy or breast feeding 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 | 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 | Japan |
| Telephone | |
| Affiliation | Kinki University School of Medicine Department of Medical Oncology |
| scientific contact | |
| Name | Isamu Okamoto |
| Address | 377-2 Ohno-higashi, Osaka-Sayama, Japan |
| Telephone | |
| Affiliation | Kinki University School of Medicine Department of Medical Oncology |