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Phase I Study in RAD 001 Patients With Relapse AML

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074086
First Posted: February 24, 2010
Last Update Posted: December 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
  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: 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

Resource links provided by NLM:


Further study details as provided by French Innovative Leukemia Organisation:

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

  • Biological study [ Time Frame: Day 1 and Day 7 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
France
Sophie Park
Paris, France, 75014
Sponsors and Collaborators
French Innovative Leukemia Organisation
Novartis Pharmaceuticals
Investigators
Principal Investigator: Sophie PARK, MD MS French Innovative Leukemia Organisation
Principal Investigator: Didier BOUSCArY, MD MS French Innovative Leukemia Organisation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT01074086     History of Changes
Other Study ID Numbers: RAD 001
First Submitted: February 22, 2010
First Posted: February 24, 2010
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:
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents