Phase I Study in RAD 001 Patients With Relapse AML

AML Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074086
• Other study ID #: RAD 001
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2010
• Last updated: December 21, 2012
• Start date: February 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML

Intervention

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

Locations

Country	Name	City	State
France	Sophie Park	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS	Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal dose tolerated	5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step	40 days	Yes
Secondary	Biological study	biological study of PI3K/AKT an mTORC1 activation in blast cells	Day 1 and day 7	Yes
Secondary	Biological study	concentration mesures of RAD 001 in total blood	Day 1 and Day 7	Yes