Clinical trial · Interventional
Study of XIAP Antisense for Advanced Cancers
A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
NCT00385775CI-TRIAL-00001651terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Dosing cohort (650mg) exceeded current 350mg dosing in other trials.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEG35156 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells.
- timeFrame
- 1 year
- measure
- Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells.
- timeFrame
- 1 year
- measure
- Determine the plasma pharmacokinetic profile of AEG35156.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.