Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate
PALANGI3
1 other identifier
interventional
26
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started Feb 2009
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 13, 2026
March 1, 2026
2.1 years
January 11, 2010
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
For safety: NCI-CTCAE scale version 3.0
42 days
Secondary Outcomes (1)
For anti tumoral efficiency : RECIST criteria
70 days
Interventions
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
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
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)
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
Eligibility Criteria
You may qualify if:
- Rare tumor
- metastatic disease or locally advanced disease, inoperable, with no standard treatment
- At least 28 days since the prior treatment
- Measurable disease with at least one measurable lesion
You may not qualify if:
- Medullary insufficiency
- Cystitis, haemorrhagic cystitis
- Hepatic porphyria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Institut Bergonié
Bordeaux, 33076, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69008, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine ADENIS, MD, PhD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 12, 2010
Study Start
February 9, 2009
Primary Completion
April 1, 2011
Study Completion
February 1, 2012
Last Updated
March 13, 2026
Record last verified: 2026-03