JRCT ID: jRCTs041180114
Registered date:19/03/2019
Phase II clinical trial of pazopanib for specific soft tissue sarcoma
Basic Information
| Recruitment status | Complete |
|---|---|
| Health condition(s) or Problem(s) studied | 1st cohort: malignant peripheral nerve sheath tumor 2nd cohort: alveolar soft part sarcoma, epitheli |
| Date of first enrollment | 27/12/2016 |
| Target sample size | 46 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | pazopanib 800mg/day, oral administration |
Outcome(s)
| Primary Outcome | clinical benefit rate at 12 weeks (RECIST) |
|---|---|
| Secondary Outcome | clinical benefit rate at 12 weeks (Choi), response rate and progression free survival (RECIST/Choi), overall survival, safety |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1st cohort: patients with unresectable or metastatic malignant peripheral nerve sheath tumor, 2nd cohort: patients with unresectable or metastatic chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma |
| Exclude criteria | cerebrovascular disease, gastrointestinal disorder, bleeding tendency, hypersensitivity, pregnancy |
Related Information
| Primary Sponsor | Nishida Yoshihiro |
|---|---|
| Secondary Sponsor | Novartis Pharma K.K.,Japanese Musculoskeletal Oncology Group |
| Source(s) of Monetary Support | |
| Secondary ID(s) | UMIN000019303 |
Contact
| Public contact | |
| Name | Hiroshi Urakawa |
| Address | 65 Tsurumai Showa-ku, Nagoya city Aichi Japan 466-8550 |
| Telephone | +81-52-744-1902 |
| urakawa@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Hospital |
| Scientific contact | |
| Name | Yoshihiro Nishida |
| Address | 65 Tsurumai Showa-ku, Nagoya city Aichi Japan 466-8550 |
| Telephone | +81-52-744-1908 |
| ynishida@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Hospital |