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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse
The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD 001 | Experimental | RAD 001 in day 1 and day 7 from 10 mg to 50 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD 001 | Drug | RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximal dose tolerated | 5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step | 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biological study | biological study of PI3K/AKT an mTORC1 activation in blast cells | Day 1 and day 7 |
| Biological study | concentration mesures of RAD 001 in total blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie PARK, MD MS | French Innovative Leukemia Organisation | Principal Investigator |
| Didier BOUSCArY, MD MS | French Innovative Leukemia Organisation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sophie Park | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23321953 | Derived | Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16. |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Day 1 and Day 7 |