At a glance
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Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
In Brief
A Phase 1 clinical trial evaluating sunitinib for Non GIST Sarcomas. Completed, enrolled 25 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
All patients will be treated with sunitinib (2 dose levels) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib. Dose level 1 : 25 mg once daily Dose level 2 : 37.5 mg once daily Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring.