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Acute Myeloid LeukemiaPhase 1/2NCT00762632

Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia

A Phase 1/2 study testing NILOTINIB and EVEROLIMUS in people with Acute Myeloid Leukemia, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
NILOTINIB and EVEROLIMUS
How many people
40 participants
Where
1 siteGermany
Study dates
Dec 2007to Jun 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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
  • Unstable angina diagnosed or treated during the past 12 months
  • Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
  • Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control.
  • Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study.
  • Patients who had more than 2 prior regimens for their current relapsed or current primary refractory disease
  • Patients with uncontrolled active infection.
  • Patient with any pulmonary infiltrate on the baseline chest X-ray known to be new in the previous 4 weeks. Prior treatment with any investigational drug within the preceding 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
  • Hypokalemia
  • Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an highly effective method of birth control.
  • Patients who have received prior treatment with an mTor inhibitor.
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medical faculty of the Technical University Munich

    Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: An Open-label Phase I/II (Proof of Concept) Trial of an Combination of Nilotinib (AMN 107) and RAD001 in Patients With Acute Myeloid Leukemia

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.

Being tested
NILOTINIB, EVEROLIMUS
Keywords
patients with c-kit+ AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: four years

Secondary outcomes (1)

  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

    Measured: four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00762632
Sponsor's protocol ID
CAMN107ADE01
Status last verified
Aug 2012
First submitted
29 Sep 2008
Last updated
8 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NILOTINIB and EVEROLIMUS in people with Acute Myeloid Leukemia, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the rate of hematological response in adult patients with c-kit + AML. state the primary objective of the study (time frame: four years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00762632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.

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