Phase I Study in RAD 001 Patients With Relapse AML

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT01074086
First received: February 22, 2010
Last updated: December 21, 2012
Last verified: December 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • maximal dose tolerated [ Time Frame: 40 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    biological study of PI3K/AKT an mTORC1 activation in blast cells

  • Biological study [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074086

Locations
France
Sophie Park
Paris, France, 75014
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Novartis Pharmaceuticals
Investigators
Principal Investigator: Sophie PARK, MD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: Didier BOUSCArY, MD MS Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT01074086     History of Changes
Other Study ID Numbers: RAD 001
Study First Received: February 22, 2010
Last Updated: December 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
RAD 001 in relapsed AML

Additional relevant MeSH terms:
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014