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Leukemia, Myelomonocytic, AcutePhase 1/2NCT00363974

Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML

A Phase 1/2 study testing XIAP antisense in people with Leukemia, Myelomonocytic, Acute, run by Aegera Therapeutics at 7 sites in 2 countries.

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

The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myelomonocytic, Acute
What is being tested?
XIAP antisense
Type of treatment
Injection or infusion
How many people
54 participants
Where
7 sitesin 2 countries
Study dates
Oct 2005to Mar 2009
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

  • Subjects with relapsed or refractory AML, except those with APL (acute promyelocytic leukemia), that are about to receive their initial treatment for first relapse after an initial CR that lasted less than 6 months or for primary refractory AML that have an expected complete response rate ≤20%. The initial diagnosis of AML has to be based on the presence of > 10% blasts in marrow or blood, and the diagnosis of relapsed/refractory AML based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100,000 /uL, or neutrophil count < 1000 /uL).
  • Peripheral AML blast count < 50,000 /uL that is not projected to rise above 50,000 /uL within 5 days of beginning treatment.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Subjects must be >18 years old.
  • Male, or female subjects who are post-menopausal (amenorrhagic for at least 12 months), or surgically or biologically sterile. Females of childbearing potential with a negative serum pregnancy test 72-96 hours prior to the 1st infusion in the study and using adequate forms of contraception for the duration of the study, including 30 days after the last treatment. Adequate methods of contraception should be used by both male and female subjects.
  • Subjects must have adequate organ and immune function as indicated by the following laboratory values:
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  • Parameter Laboratory Values
  • Serum creatinine; <2.0mg/dL
  • Total Bilirubin <2.0mg/dL
  • AST (SGOT) and ALT (SGPT) <3 X ULN * *ULN: Institution's upper limit of normal.
  • The subject must understand and be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
  • The subject, or the subject's legal guardian, must have given written personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.

Who cannot join

  • Clinical evidence of active CNS leukemic involvement.
  • Patients with left-ventricular ejection fractions <50%.
  • Active and uncontrolled infection. Patients with an infection that are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
  • Current evidence of invasive fungal infection (blood or tissue culture).
  • Current evidence of an active second malignancy except for non-melanoma skin cancer.
  • Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a subject's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
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  • Neurological or psychiatric disorders that would interfere with consent or study follow-up.
  • Known or suspected intolerance or hypersensitivity to the study materials [or closely related compounds] or any of their stated ingredients.
  • History of alcohol or other substance abuse within the last year.
  • Use of another investigational agent or participation in a clinical trial within the last 14 days prior to enrolment. Subjects who have used a previous AS agent for at least 90 days will be excluded.
  • Female subjects who are pregnant or lactating, or females with a positive pregnancy test at screening must be excluded.
  • Subjects that have previously been enrolled into this study and subsequently withdrawn must also be excluded.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States5 sites

  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Norris Cancer Center - University of Southern California

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

Other trials in United States

Canada2 sites

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: An Open-Label Phase I/II Study of XIAP Antisense AEG35156 Administered to Patients With Refractory/Relapsed AML in Combination With Chemotherapy

The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML.

Read the detailed description

This is a phase I/II, single-arm, open-label, study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions. Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75, 110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3, starting at 12mg/m2, and not skipping any untried dose level when escalating. Following dose escalation, approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook (2004).

Being tested
XIAP antisense
Keywords
AML, leukemia, relapse, refractory, antisense, oligonucleotide
Medical subject headings
Leukemia, Myelomonocytic, Acute, Leukemia, Recurrence

What participants receive

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

  • XIAP antisenseDrug

    2 days loading dose followed by weekly 2hr infusion

What is being measured

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

  1. Dose at which AEG35156 when combined with fixed doses of ara-C and idarubicin, produces acceptable CR and toxicity rates as defined and observed at 30 days post-last dose

    Measured: 1 year

Secondary outcomes (1)

  1. Effects of AEG35156 on XIAP mRNA and protein expression and plasma pharmacokinetic profile of AEG35156.

    Measured: 1 year

Timeline

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

  1. First posted15 Aug 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363974
Sponsor's protocol ID
AEG35156-103
Other IDs
MDA 2005-0384, PMH 05-0452-C
Status last verified
Nov 2009
First submitted
10 Aug 2006
Last updated
1 Dec 2009
Results posted
No
Data monitoring committee
No

Publications

  • Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics. 2004 Sep;60(3):684-93. doi: 10.1111/j.0006-341X.2004.00218.x.

    PubMed 15339291

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XIAP antisense in people with Leukemia, Myelomonocytic, Acute, run by Aegera Therapeutics at 7 sites in 2 countries.

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 12 inclusion and 12 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 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. 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?

Dose at which AEG35156 when combined with fixed doses of ara-C and idarubicin, produces acceptable CR and toxicity rates as defined and observed at 30 days post-last dose (time frame: 1 year). 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 NCT00363974, which also lists 1 linked publication.

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 1 Dec 2009.

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