Clinical trial · Interventional
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia
A Phase I Dose Finding Study of Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia (AML) Unfit for Intensive Induction Chemotherapy
NCT00636922CI-TRIAL-00009468unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 secondary goals are to investigate the likely causes of drug response or failure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001(Everolimus) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus with 5-azacitidine
- description
- Everolimus increasing oral doses days 5-21 each cycle 5-azacitidine 75mg sub cutaneously 7 doses in 21 days
- interventionNames
- Drug: RAD001(Everolimus)
Primary outcomes (1)
- measure
- safety & tolerability
- timeFrame
- over 24 cycles of treatment
- description
- haematological toxicities (marrow status, neutrophil recovery), non-haematological grade 4 toxicity
Secondary outcomes (3)
- measure
- clinical Response
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.