Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia

PHASE1UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

July 31, 2013

Study Completion Date

January 31, 2014

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

RAD001(Everolimus)

In this study, 5-azacitidine will be administered sc for 7 doses over 9 days in a 28 day cycle. Everolimus will be administered orally with the first dose starting on day 5 (first Friday) of each cycle and continued until day 21 of each cycle. Patients will be treated with combined azacitidine + Everolimus for a minimum of 6 cycles and until at least 2 cycles after documentation of CR. Upon cessation of azacitidine, the patient will be permitted to take Everolimus maintenance therapy until progression at the investigator's discretion.

Trial Locations (1)

3004

BaysideHealth, The Alfred Hospital, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayside Health

OTHER_GOV

NCT00636922 - Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter