NCT00762632

Brief Summary

This is a nonrandomized, open-label study to evaluate the efficacy and safety of combination treatment of Nilotinib and RAD001 in the treatment of c-kit + AML. Patients refractory to standard chemotherapy or not eligible to standard chemotherapy can be included. Patients will be treated with 400 mg Nilotinib bid (total daily dose 800 mg). RAD001 will be added after a treatment duration of 1 week in a dosage of 2,5 mg/day. Treatment duration will be 25 weeks.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-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

December 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

4.5 years

First QC Date

September 29, 2008

Last Update Submit

August 7, 2012

Conditions

Acute Myeloid Leukemia

Keywords

patients with c-kit+ AML

Outcome Measures

Primary Outcomes (1)

  • To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study

    four years

Secondary Outcomes (1)

  • To determine the duration of hematological response. To evaluate overall survival. To evaluate the safety profile of a combination treatment of Nilotinib and RAD001. • To evaluate improvement of symptomatic parameters. • To assess mTor, cKit a

    four years

Interventions

NILOTINIBDRUG

400 mg Nilotinib bid (total daily dose 800 mg) should be continued 25 weeks

EVEROLIMUSDRUG

Everolimus at 2,5 mg/day should be continued 25 weeks.

Eligibility Criteria

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

You may qualify if:

  • Patients with:
  • De novo AML or secondary AML from MDS who are not candidates for myelosuppressive chemotherapy, or
  • De novo AML or secondary AML from MDS who have relapsed disease or are refractory to standard therapy
  • Patients at least 18 years or older
  • Patients with WHO performance status of 0 to 2 with a life expectancy under treatment of at least 3 months
  • Patients must have recovered from prior cytotoxic chemotherapy; treatment with Hydroxyurea or Ara-C is allowed until 24 hours to first administration of study drug.
  • Patients must have a serum creatinine of \<= 1.5 x ULN, SGOT/SGPT \<= 3 x ULN and total bilirubin \<= 2.0 x ULN
  • Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Written informed consent obtained according to local guidelines

You may not qualify if:

  • Patients with AML FAB M3.
  • Patients with an expected doubling of the peripheral blast within one week.
  • Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously.
  • Impaired cardiac function, including any one of the following:
  • LVEF \< 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by MUGA scan or echocardiogram
  • Complete left bundle branch block
  • Use of a cardiac pacemaker
  • ST depression of \> 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads
  • Congenital long QT syndrome dose levels of 400 to 1200 mg QD. Many of the common adverse events reported in the imatinib Phase II leukemia (STI0106, STI0110) studies were also reported in the nilotinib Phase I study, although a notably lower frequency of peripheral edema was identified in the nilotinib study.
  • History of or presence of significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia (\< 50 beats per minute)
  • QTc \> 450 msec on screening ECG (using the QTcF formula)
  • QT prolonging concomitant medication
  • Right bundle branch block plus left anterior hemiblock, bifascicular block
  • Myocardial infarction within 12 months prior to starting Nilotinib
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical faculty of the Technical University Munich

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

nilotinibEverolimus

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Justus Prof. Duyster, MD

    Medical faculty of the Technical University Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

DE(1)