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

Cancer Clinical Trial

— PALANGI3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046487
• Other study ID #: PALANGI-3 0804
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2010
• Last updated: June 6, 2012
• Start date: January 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Medullary insufficiency

• Cystitis, haemorrhagic cystitis

• Hepatic porphyria

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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
• 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
• 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)

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For safety: NCI-CTCAE scale version 3.0		42 days	Yes
Secondary	For anti tumoral efficiency : RECIST criteria		70 days	No