NCT01074086

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

4.8 years

First QC Date

February 22, 2010

Last Update Submit

December 21, 2012

Conditions

AML

Keywords

RAD 001 in relapsed AML

Outcome Measures

Primary Outcomes (1)

  • maximal dose tolerated

    5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step

    40 days

Secondary Outcomes (2)

  • Biological study

    Day 1 and day 7

  • Biological study

    Day 1 and Day 7

Study Arms (1)

RAD 001

EXPERIMENTAL

RAD 001 in day 1 and day 7 from 10 mg to 50 mg

Drug: RAD 001

Interventions

RAD 001DRUG

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

Also known as: everolimus
RAD 001

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients from 18 to 65 years old
  • AML in relapse more than 1 year after CR
  • inform consent signed

You may not qualify if:

  • age more than 65
  • cardiac insufficiency
  • renal insufficiency
  • hepatic disease
  • other type of AML
  • blastic MCL
  • HIV positive serology
  • other malignancy
  • pulmonary infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sophie Park

Paris, 75014, France

Location

Related Publications (1)

  • Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.

    PMID: 23321953DERIVED

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Sophie PARK, MD MS

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

  • Didier BOUSCArY, MD MS

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

February 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations

FR(1)