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Completed

NCT Number: NCT01074086

Phase I Study in RAD 001 Patients With Relapse AML

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

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Key information

Conditions

AML

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sophie Park

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAD 001

Drug

RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg

Other names: everolimus

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2010
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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