Advanced TumorPhase 1NCT00502060
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer
A Phase 1 study testing AZD2171 and ZD1839 in people with Advanced Tumor, run by AstraZeneca at 3 sites in Netherlands.
Trial summary
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Tumor
- What is being tested?
- AZD2171 and ZD1839
- How many people
- 65 participants
- Where
- 3 sitesNetherlands
- Study dates
- Aug 2004to Jun 2006
- 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
- tumor progressed on standard therapy or ineligible for standard therapy
- life expectancy of 12 weeks or more
- WHO performance status 0-2
Who cannot join
- History of active interstitial lung disease
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Research Site
Amsterdam
Research Site
Nijmegen
Research Site
Utrecht
About this study
Official title: A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer
- Conditions
- Advanced Tumor
- Being tested
- AZD2171, ZD1839
- Keywords
- Phase I, AZD2171, ZD1839, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
ZD1839Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
Secondary outcomes (1)
to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days
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 startAug 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nick Botwood, BSc, MBBS, MRCP, MFPM, Study director, AstraZenecaG Giaccone, Prof, Principal investigator, Vrije Universiteit Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502060
- Sponsor's protocol ID
- D8480C00004
- Status last verified
- May 2009
- First submitted
- 13 Jul 2007
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00502060
- Acronym / sponsor ID
- D8480C00004
- Conditions
- Advanced Tumor
- Keywords
- Phase I, AZD2171, ZD1839, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- 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.
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer
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 (3 listed)
- tumor progressed on standard therapy or ineligible for standard therapy
- life expectancy of 12 weeks or more
- WHO performance status 0-2
Key exclusion criteria (1 listed)
- History of active interstitial lung disease
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 | – |
| ZD1839 | Drug | – |
Primary outcome
primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
1 secondary outcome
to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days
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 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.
Nick Botwood, BSc, MBBS, MRCP, MFPM study director
AstraZeneca
G Giaccone, Prof principal investigator
Vrije Universiteit Medical Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2171 and ZD1839 in people with Advanced Tumor, run by AstraZeneca at 3 sites in Netherlands.
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 3 inclusion and 1 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 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 Netherlands. 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 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?
primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839. 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.