UMIN ID: C000000073
Registered date:22/08/2005
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Sarcoma with c-kit or PDGFR expression by immunohistochemistry |
| Date of first enrollment | 2005/03/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Imatinib 600mg once a day |
Outcome(s)
| Primary Outcome | Response rate in patients with Imatinib 600mg/day |
|---|---|
| Secondary Outcome | 1) Response rate in patients with Imatinib 800mg/day 2) Adverse events 3) Time to progression 4) To evaluate relationships between response and profile of gene expression 5) Pharmacokinetics in adolescence patients |
Key inclusion & exclusion criteria
| Age minimum | 12years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) controlable or active infection 2) pregnacy or lactation 3) brain metastasis with clinical symptom |
Related Information
| Primary Sponsor | Office of Imatinib phase2 study |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Center for Clinical Trials, Japan Medical Association |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masashi Ando, MD |
| Address | Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN Japan |
| Telephone | 03-3542-2511 |
| mandoh@ncc.go.jp | |
| Affiliation | Office of Imatinib phase2 study Dept of Medical Oncology, National Cancer Center Hospital |
| scientific contact | |
| Name | Yasuhiro Fujiwara, MD, PhD |
| Address | Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Chief of Breast and Medical Oncology Division, Director of Outpatient Treatment Center, Director of Clinical Trial Coodinating Office |