Study Stopped
Dosing cohort (650mg) exceeded current 350mg dosing in other trials.
Study of XIAP Antisense for Advanced Cancers
A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2006
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 21, 2008
August 1, 2008
2.3 years
October 6, 2006
August 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Interventions
weekly IV solution infused over 2 hrs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Jacques Jolivet, MD
Aegera Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 11, 2006
Study Start
June 1, 2006
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
August 21, 2008
Record last verified: 2008-08