LeukaemiaPhase 1NCT00502385
Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML
A Phase 1 study testing AZD2171 in people with Leukaemia and Myelocytic, run by AstraZeneca.
Trial summary
The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukaemia, Myelocytic, Acute
- What is being tested?
- AZD2171
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to not given
- 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
- Provision of written informed consent
- Male/female, 18 yrs or over
- WHO performance status 0-2
- Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy
Who cannot join
- Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3
- Previous treatment against new blood vessel formation (anti-angiogenic)
- Chest X-ray showing leukaemia in the lungs
About this study
The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.
- Conditions
- Leukaemia, Myelocytic, Acute
- Being tested
- AZD2171
- Keywords
- Phase I, AML, de novo or secondary AML, AZD2171
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry
Secondary outcomes (1)
Efficacy, PK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nick Botwood, BSc, MBBS, MRCP, MFPM, Study director, AstraZenecaDieter Hoelzer, MD, PhD, Principal investigator, Frankfurt University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502385
- Sponsor's protocol ID
- D8480C00002
- Status last verified
- Jan 2011
- First submitted
- 13 Jul 2007
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML
- ClinicalTrials.gov ID
- NCT00502385
- Acronym / sponsor ID
- D8480C00002
- Conditions
- Leukaemia, Myelocytic, Acute
- Keywords
- Phase I, AML, de novo or secondary AML, AZD2171
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 17 Jul 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 study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Provision of written informed consent
- Male/female, 18 yrs or over
- WHO performance status 0-2
- Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy
Key exclusion criteria (3 listed)
- Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3
- Previous treatment against new blood vessel formation (anti-angiogenic)
- Chest X-ray showing leukaemia in the lungs
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 |
|---|---|---|
| AZD2171 | Drug | – |
Primary outcome
The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry
1 secondary outcome
Efficacy, PK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
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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.
Nick Botwood, BSc, MBBS, MRCP, MFPM study director
AstraZeneca
Dieter Hoelzer, MD, PhD principal investigator
Frankfurt University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2171 in people with Leukaemia and Myelocytic, run by AstraZeneca.
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 3 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: finished, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry. 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 Jan 2011.