Study of XIAP Antisense for Advanced Cancers

Aegera Therapeutics

Status and phase

Terminated

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: AEG35156

Study type

Interventional

Funder types

Industry

Identifiers

NCT00385775

AEG35156-104

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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