Status:
UNKNOWN
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia
Lead Sponsor:
Bayside Health
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main goal of this study is to assess the safety and tolerability of RAD001 in combination with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy. The secondar...
Detailed Description
A multicentre 2-stage Phase Ib/II trial of 5-Azacitidine combined with Everolimus for AML patients over the age of 60 or relapsed AML over the age of 18. The MTD and DLT of 5-Azacitidine (7 doses over...
Eligibility Criteria
Inclusion
- Untreated AML patients (defined by WHO 2008 criteria) over the age of 60 or relapsed/refractory AML over the age of 18 who have received up to 2 previous lines of intensive chemotherapy
- No prior failure to achieve at least a PR with Azacitidine or Everolimus
- Provision of written informed consent
- Secondary AML (including therapy-related) are included
- Life expectancy of greater than 3 months in relation to diseases other then AML/MDS
- ECOG performance status 0 - 3
- Electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements
- Adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Adequate renal function, with serum creatinine ≤ 1.5 x ULN or GFR \> 30 ml/minute
- Patients with no uncontrolled active infection
- Hydroxyurea ceased 48 hours prior to study therapy
- Exclusion Criteria
- Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
- History of major non-compliance to medication
- Evidence of CNS leukemia
- Uncontrolled viral infection with known HIV or Hepatitis type B or C
- Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
- Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
- Males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00636922
Start Date
February 1 2010
End Date
January 1 2014
Last Update
February 15 2013
Active Locations (1)
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1
BaysideHealth, The Alfred Hospital
Melbourne, Victoria, Australia, 3004