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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01046487 |
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Date of registration:
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11/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate
PALANGI3 |
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Scientific title:
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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01046487 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Antoine ADENIS, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Oscar Lambret |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2)
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Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)
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Procedure: Blood sampling
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Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 )
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Primary Outcome(s)
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For safety: NCI-CTCAE scale version 3.0
[Time Frame: 42 days]
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Secondary Outcome(s)
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For anti tumoral efficiency : RECIST criteria
[Time Frame: 70 days]
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Secondary ID(s)
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PALANGI-3 0804
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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