Advanced Cancer
Conditions
Keywords
Cancer, solid tumours, refractory, antisense, oligonucleotide
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.
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.
Interventions
DRUGAEG35156
weekly IV solution infused over 2 hrs
Sponsors
Aegera Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed