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Phase I Study in RAD 001 Patients With Relapse AML

Primary Purpose

AML

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
RAD 001
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring RAD 001 in relapsed AML

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sophie Park

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD 001

Arm Description

RAD 001 in day 1 and day 7 from 10 mg to 50 mg

Outcomes

Primary Outcome Measures

maximal dose tolerated
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step

Secondary Outcome Measures

Biological study
biological study of PI3K/AKT an mTORC1 activation in blast cells
Biological study
concentration mesures of RAD 001 in total blood

Full Information

First Posted
February 22, 2010
Last Updated
December 21, 2012
Sponsor
French Innovative Leukemia Organisation
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01074086
Brief Title
Phase I Study in RAD 001 Patients With Relapse AML
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
Keywords
RAD 001 in relapsed AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD 001
Arm Type
Experimental
Arm Description
RAD 001 in day 1 and day 7 from 10 mg to 50 mg
Intervention Type
Drug
Intervention Name(s)
RAD 001
Other Intervention Name(s)
everolimus
Intervention Description
RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
Primary Outcome Measure Information:
Title
maximal dose tolerated
Description
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Biological study
Description
biological study of PI3K/AKT an mTORC1 activation in blast cells
Time Frame
Day 1 and day 7
Title
Biological study
Description
concentration mesures of RAD 001 in total blood
Time Frame
Day 1 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie PARK, MD MS
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier BOUSCArY, MD MS
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sophie Park
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23321953
Citation
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.
Results Reference
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Phase I Study in RAD 001 Patients With Relapse AML

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