UMIN ID: UMIN000001101
Registered date:20/04/2008
Phase I study of weekly amrubicin in patients with refractory or relapsed lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | lung cancer |
| Date of first enrollment | 2006/04/01 |
| Target sample size | 18 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Weekly (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochloride |
Outcome(s)
| Primary Outcome | Evaluation of safety Pharmacokinetic study at the first cycle |
|---|---|
| Secondary Outcome | Response rate in assessable patients |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Contraindication for amrubicin 2. Carcinomatous pleuritis, pericarditis, pritonitis with local therapy indication 3. Patient can not enroll during radiotherapy, but can be registered after interval (chest: four weeks; without chest: one weeks). 4. Serious medical complication: Uncontrolled angina pectoris, myocardial infarction for less than 3 months; patient with cardiac failure. Uncontrolled diabetes mellitus, hypertension. 5. Infected patients 6. Other clinical difficulties in this study |
Related Information
| Primary Sponsor | Central Japan Lung Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Central Japan Lung Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Chiyoe Kitagawa |
| Address | Japan |
| Telephone | |
| Affiliation | National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |
| scientific contact | |
| Name | Chiyoe Kitagawa |
| Address | 4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-951-1111 |
| Affiliation | National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |