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A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers

Phase 1
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers

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.

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

- hepatitis B, C or Human Immunodeficiency Virus

- allergic history to antisense agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Jacques Jolivet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Aegera Therapeutics Inc.


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2006

Completion Date:

November 2008

Related Keywords:

  • Advanced Cancer
  • Cancer
  • solid tumours
  • refractory
  • antisense
  • oligonucleotide
  • Neoplasms