Phase I Study in RAD 001 Patients With Relapse AML
This study has been completed.
Sponsor:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT01074086
First received: February 22, 2010
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
AML |
Drug: RAD 001 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission |
Resource links provided by NLM:
Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Primary Outcome Measures:
- maximal dose tolerated [ Time Frame: 40 days ] [ Designated as safety issue: Yes ]5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
Secondary Outcome Measures:
- Biological study [ Time Frame: Day 1 and day 7 ] [ Designated as safety issue: Yes ]biological study of PI3K/AKT an mTORC1 activation in blast cells
- Biological study [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: Yes ]concentration mesures of RAD 001 in total blood
| Enrollment: | 31 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RAD 001
RAD 001 in day 1 and day 7 from 10 mg to 50 mg
|
Drug: RAD 001
RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
Other Name: everolimus
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients from 18 to 65 years old
- AML in relapse more than 1 year after CR
- inform consent signed
Exclusion Criteria:
- age more than 65
- cardiac insufficiency
- renal insufficiency
- hepatic disease
- other type of AML
- blastic MCL
- HIV positive serology
- other malignancy
- pulmonary infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074086
Locations
| France | |
| Sophie Park | |
| Paris, France, 75014 | |
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Sophie PARK, MD MS | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| Principal Investigator: | Didier BOUSCArY, MD MS | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
More Information
Additional Information:
No publications provided
| Responsible Party: | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
| ClinicalTrials.gov Identifier: | NCT01074086 History of Changes |
| Other Study ID Numbers: | RAD 001 |
| Study First Received: | February 22, 2010 |
| Last Updated: | December 21, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
|
RAD 001 in relapsed AML |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 17, 2013