Study of XIAP Antisense for Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385775
Recruitment Status : Terminated (Dosing cohort (650mg) exceeded current 350mg dosing in other trials.)
First Posted : October 11, 2006
Last Update Posted : August 21, 2008
Information provided by:
Aegera Therapeutics

Brief Summary:
This study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: AEG35156 Phase 1

Detailed Description:
This is a Phase I study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. The starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
Study Start Date : June 2006
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : November 2008

Intervention Details:
    Drug: AEG35156
    weekly IV solution infused over 2 hrs

Primary Outcome Measures :
  1. Dose level at which AEG35156 is well tolerated based upon development of toxicities during the first cycle of therapy unless delayed or cumulative toxicity is encountered. Assessments done weekly. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells. [ Time Frame: 1 year ]
  2. Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells. [ Time Frame: 1 year ]
  3. Determine the plasma pharmacokinetic profile of AEG35156. [ Time Frame: 1 year ]
  4. Determine the possible anti-tumour activity of XIAP. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically proven diagnosis of advanced or metastatic cancer (including solid tumours and lymphoma)
  • refractory to conventional treatment, or for which no conventional therapy exists with life expectancy of at least 12 weeks
  • ECOG performance status of 0 or 1
  • hematological and biochemical indices as specified within one week prior to treatment

Exclusion Criteria:

  • known bleeding diathesis or concurrent treatment with anticoagulants
  • primary brain tumours or brain metastases
  • radiotherapy (except palliative), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C)
  • all toxic manifestations of previous treatment must have resolved (excepting alopecia or certain Grade 1 toxicities)
  • pregnant or lactating women
  • major thoracic and/or abdominal surgery in the preceding 4 weeks
  • high medical risks from non-malignant systemic disease including uncontrolled infection
  • hepatitis B, C or Human Immunodeficiency Virus
  • allergic history to antisense agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00385775

United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Aegera Therapeutics
Study Director: Jacques Jolivet, MD Aegera Therapeutics Inc.

Responsible Party: Jacques Jolivet, MD, Senior VP Clinical, Aegera Therapeutics Inc Identifier: NCT00385775     History of Changes
Other Study ID Numbers: AEG35156-104
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

Keywords provided by Aegera Therapeutics:
solid tumours

Additional relevant MeSH terms: