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Phase I Study in RAD 001 Patients With Relapse AML

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ClinicalTrials.gov Identifier: NCT01074086
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : December 24, 2012
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
AML Drug: RAD 001 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. maximal dose tolerated [ Time Frame: 40 days ]
    5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step


Secondary Outcome Measures :
  1. Biological study [ Time Frame: Day 1 and day 7 ]
    biological study of PI3K/AKT an mTORC1 activation in blast cells

  2. Biological study [ Time Frame: Day 1 and Day 7 ]
    concentration mesures of RAD 001 in total blood


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074086


Locations
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France
Sophie Park
Paris, France, 75014
Sponsors and Collaborators
French Innovative Leukemia Organisation
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Sophie PARK, MD MS French Innovative Leukemia Organisation
Principal Investigator: Didier BOUSCArY, MD MS French Innovative Leukemia Organisation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT01074086    
Other Study ID Numbers: RAD 001
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012
Keywords provided by French Innovative Leukemia Organisation:
RAD 001 in relapsed AML
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Everolimus
 Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs