Phase I Study in RAD 001 Patients With Relapse AML

December 21, 2012 updated by: French Innovative Leukemia Organisation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Sophie Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal dose tolerated
Time Frame: 40 days
5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step
40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological study
Time Frame: Day 1 and day 7
biological study of PI3K/AKT an mTORC1 activation in blast cells
Day 1 and day 7
Biological study
Time Frame: Day 1 and Day 7
concentration mesures of RAD 001 in total blood
Day 1 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Sophie PARK, MD MS, French Innovative Leukemia Organisation
  • Principal Investigator: Didier BOUSCArY, MD MS, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAD 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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