Study of XIAP Antisense for Advanced Cancers

Sponsor

Aegera Therapeutics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00385775

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2006

Anticipated Primary Completion Date :

Oct 1, 2008

Anticipated Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

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. [1 year]

Secondary Outcome Measures

Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells. [1 year]
Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells. [1 year]
Determine the plasma pharmacokinetic profile of AEG35156. [1 year]
Determine the possible anti-tumour activity of XIAP. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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