NCT00363974

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

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

October 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

3.4 years

First QC Date

August 10, 2006

Last Update Submit

November 30, 2009

Conditions

Leukemia, Myelomonocytic, Acute

Keywords

AMLleukemiarelapserefractoryantisenseoligonucleotide

Outcome Measures

Primary Outcomes (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

    1 year

Secondary Outcomes (1)

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

    1 year

Interventions

XIAP antisenseDRUG

2 days loading dose followed by weekly 2hr infusion

Eligibility Criteria

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

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Norris Cancer Center - University of Southern California

Los Angeles, California, 90033, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 15339291BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelomonocytic, AcuteLeukemiaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacques Jolivet, MD

    Aegera Therapeutics Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

October 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

US(5)CA(2)