Advanced CancerPhase 1NCT00385775
Study of XIAP Antisense for Advanced Cancers
A Phase 1 study testing AEG35156 in people with Advanced Cancer, run by Aegera Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AEG35156
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- high medical risks from non-malignant systemic disease including uncontrolled infection
- hepatitis B, C or Human Immunodeficiency Virus
- allergic history to antisense agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- AEG35156
- Keywords
- Cancer, solid tumours, refractory, antisense, oligonucleotide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEG35156Drug
weekly IV solution infused over 2 hrs
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells.
Measured: 1 year
Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells.
Measured: 1 year
Determine the plasma pharmacokinetic profile of AEG35156.
Measured: 1 year
Determine the possible anti-tumour activity of XIAP.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: Dosing cohort (650mg) exceeded current 350mg dosing in other trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aegera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques Jolivet, MD, Study director, Aegera Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385775
- Sponsor's protocol ID
- AEG35156-104
- Status last verified
- Aug 2008
- First submitted
- 6 Oct 2006
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT00385775
- Acronym / sponsor ID
- AEG35156-104
- Conditions
- Advanced Cancer
- Keywords
- Cancer, solid tumours, refractory, antisense, oligonucleotide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dosing cohort (650mg) exceeded current 350mg dosing in other trials.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aegera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEG35156weekly IV solution infused over 2 hrs | Drug | – |
Primary outcome
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.
Time frame: 1 year
4 secondary outcomes
Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells.
Time frame: 1 year
Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells.
Time frame: 1 year
Determine the plasma pharmacokinetic profile of AEG35156.
Time frame: 1 year
Determine the possible anti-tumour activity of XIAP.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Dosing cohort (650mg) exceeded current 350mg dosing in other trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Jolivet, MD study director
Aegera Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AEG35156 in people with Advanced Cancer, run by Aegera Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Dosing cohort (650mg) exceeded current 350mg dosing in other trials.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.