Status:
TERMINATED
Study of XIAP Antisense for Advanced Cancers
Lead Sponsor:
Aegera Therapeutics
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advan...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00385775
Start Date
June 1 2006
End Date
November 1 2008
Last Update
August 21 2008
Active Locations (1)
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1
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX