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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate (PALANGI3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01046487
First received: January 11, 2010
Last updated: June 6, 2012
Last verified: June 2012
January 11, 2010
June 6, 2012
January 2009
April 2011   (Final data collection date for primary outcome measure)
For safety: NCI-CTCAE scale version 3.0 [ Time Frame: 42 days ]
Same as current
Complete list of historical versions of study NCT01046487 on ClinicalTrials.gov Archive Site
For anti tumoral efficiency : RECIST criteria [ Time Frame: 70 days ]
Same as current
Not Provided
Not Provided
 
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)
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).
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • 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)

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2012
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01046487
PALANGI-3 0804
No
Not Provided
Not Provided
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
Centre Oscar Lambret
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP