Myeloid LeukemiaPhase 1NCT00543972
Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
A Phase 1 study testing AVE9633 in people with Myeloid Leukemia, run by Sanofi at 3 sites in 3 countries.
Trial summary
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- AVE9633
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2007to Aug 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
- Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
- ECOG performance status 0 to 2
Who cannot join
- Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
- Allogenic transplantation within 6 months prior to inclusion
- Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
- Previous treatment with AVE9633
- Poor kidney, liver and bone marrow functions
- Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
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- Pregnant or breast-feeding women
- Patient with reproductive potential without effective birth control methods
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.
- Conditions
- Myeloid Leukemia
- Being tested
- AVE9633
- Medical subject headings
- Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE9633Drug
Intravenous Infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Measured: Study period
Secondary outcomes (2)
Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance
Measured: Study period
Incidence of Adverse Events
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: due to absence of evidence of clinical activity up to toxic doses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543972
- Sponsor's protocol ID
- TED10219
- Other IDs
- EudraCT 2006-005976-41
- Status last verified
- May 2009
- First submitted
- 12 Oct 2007
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00543972
- Acronym / sponsor ID
- TED10219
- Conditions
- Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to absence of evidence of clinical activity up to toxic doses
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Oct 2007 (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.
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.
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 (2 listed)
- Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
- ECOG performance status 0 to 2
Key exclusion criteria (9 listed)
- Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
- Allogenic transplantation within 6 months prior to inclusion
- Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
- Previous treatment with AVE9633
- Poor kidney, liver and bone marrow functions
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 |
|---|---|---|
| AVE9633Intravenous Infusion | Drug | – |
Primary outcome
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Time frame: Study period
2 secondary outcomes
Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance
Time frame: Study period
Incidence of Adverse Events
Time frame: Study period
Results and safety
The study was stopped early (reason given: due to absence of evidence of clinical activity up to toxic doses). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
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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.
ICD CSD study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVE9633 in people with Myeloid Leukemia, run by Sanofi at 3 sites in 3 countries.
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 2 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 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France, Spain. 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: due to absence of evidence of clinical activity up to toxic doses). 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?
Incidence of Dose Limiting Toxicity(ies) at each tested dose level (time frame: Study period). 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 14 May 2009.