NCT01046487

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Imatinib mesylate, Cyclophosphamide (Dosing level 1 )	CYCLE 1 (42 days): * Day 1 to 14 Imatinib mesylate : 400 mg/day, per os * Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os
DRUG	Imatinib mesylate, Cyclophosphamide (Dosing level 2)	CYCLE 1 (42 days): * Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os * Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os
DRUG	Imatinib mesylate, Cyclophosphamide (Dosing level 3)	CYCLE 1 (42 days): * Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os * Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os
PROCEDURE	Blood sampling	ONLY FOR CYCLE 1, at day 15 and day 28 : 11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)

Timeline

• Start date: 2009-02-09
• Primary completion: 2011-04-01
• Completion: 2012-02-01
• First posted: 2010-01-12
• Last updated: 2026-03-13

Locations

3 sites across 1 country: France