NCT01308034

Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy

Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design : 2 dose levels Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily 3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment DLT is defined as : any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity \> or = 4 Secondary objectives are : * to evaluate the safety with late toxicities * to estimate the response rate at 6 months * to estimate the progression free survival * to evaluate the proportion of patients with an operable tumour after treatment Exploratory objectives are : * to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US) * to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US

Conditions

• Non GIST Sarcomas

Interventions

Type	Name	Description
DRUG	sunitinib	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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-05-01
• Completion: 2016-09-21
• First posted: 2011-03-03
• Last updated: 2022-01-18

Locations

6 sites across 1 country: France