NCT01074086

Phase I Study in RAD 001 Patients With Relapse AML

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML

Interventions

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

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-02-24
• Last updated: 2012-12-24

Locations

1 site across 1 country: France