Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia

NCT00636922 | Unknown Phase 1

• 1 other identifier: CRAD001C24112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 secondary goals are to investigate the likely causes of drug response or failure.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Elderly; Unfit; Everolimus; RAD001

Outcome Measures

Primary Outcomes (1)

• safety & tolerability

  haematological toxicities (marrow status, neutrophil recovery), non-haematological grade 4 toxicity

  over 24 cycles of treatment

Secondary Outcomes (3)

• clinical Response

  up to 3 years

• biomarkers of response

  over length of treatment up to 24 cycles

• patient related outcomes

  during treatment and in followup for up to 3 years

Study Arms (1)

Everolimus with 5-azacitidine

EXPERIMENTAL

Everolimus increasing oral doses days 5-21 each cycle 5-azacitidine 75mg sub cutaneously 7 doses in 21 days

Drug: RAD001(Everolimus)

Interventions

RAD001(Everolimus) DRUG

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.

Also known as: Everolimus

Everolimus with 5-azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

BaysideHealth, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Andrew Wei, MBBS PhD

  Bayside Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

AU (1)