Study of XIAP Antisense for Advanced Cancers

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aegera Therapeutics

Criteria

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