Phase I Study in RAD 001 Patients With Relapse AML

Phase 1

Completed

• Conditions: AML
• Interventions: Drug: RAD 001

• Registration Number: NCT01074086
• Lead Sponsor: French Innovative Leukemia Organisation

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
maximal dose tolerated	40 days	5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step

Secondary Outcome Measures

Name	Time	Method
Biological study	Day 1 and Day 7	concentration mesures of RAD 001 in total blood

Trial Locations

Locations (1)

Sophie Park; 🇫🇷 Paris, France