drugset / Trial / NCT01308034
Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery. The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery. This study is a multicentre, open-label phase I with dose escalation : 2 dose levels. 3-6 patients will be included at each dose level.3-18 patients will be included in the study.
Timeline
- Start
- 2011-03
- Primary completion
- 2016-05
- Completion
- 2016-09-21
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sunitinib | Small molecule | 25 mg | — |
| Subject | Sunitinib | Small molecule | 37.5 mg | — |