CancerPhase 1NCT00748891
DCE CT/MRI Scanning Study in Patients With Solid Tumours (AstraZeneca and Royal Marsden Hospital Imaging Study)
A Phase 1 study testing Recentin (Cediranib) in people with Cancer, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study is being carried out in patients with advanced solid tumours to assess which of two different types of imaging scans best measures activity of an experimental drug called Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and Dynamic Contrast Enhanced MRI (DCE-MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Recentin (Cediranib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Nov 2010
- 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 confirmed metastatic tumour which is refractory to standard therapies
- At least one lesion size ≥3cm on in longest diameter suitable for repeat assessment by DCE-CT and DCE-MRI
- Patients must be able to undergo DCE-CT and DCE-MRI scanning procedures
- Life expectancy of at least 12 weeks
Who cannot join
- Patients with hormone refractory prostate cancer (HRPC)
- Patients with a history of poorly controlled high blood pressure
- Ineligibility for MRI scanning or DCE-CT or DCE-MRI scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Open-Label, Non-randomised, Single Centre Methodology Study Comparing DCE-CT and DCE-MRI as Markers of Changes in Vascular Activity Mediated by a Positive Control Agent [Cediranib (Recentin™; AZD2171), a Potent Inhibitor of VEGF-driven Angiogenesis] in Patients With Advanced Solid Tumour
This study is being carried out in patients with advanced solid tumours to assess which of two different types of imaging scans best measures activity of an experimental drug called Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most accurate and best predicts a response to the treatment. Cediranib is thought to work by stopping blood flow to cancers, and both of these scans assess blood flow. Studying the response of cancers by measuring changes in their blood flow may provide useful information that will guide the way we manage cancers in the future.
- Conditions
- Cancer
- Being tested
- Recentin (Cediranib)
- Keywords
- Cancer, tumour, advanced sold tumour, imaging, DCE-CT Scan, DCE-MRI scan, Cediranib, Recentin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recentin (Cediranib)Drug
Also called Cediranib
30mg once daily, oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression Receives: Drug: Recentin (Cediranib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities.
Measured: DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1.
Baseline measurements for DCE-MRI-iAUC60(mMol/sec),Ktrans(min-1),ve,vp,kep(min-1,Enhancing Fraction% DCE-CT-Permeability Surface Product(ml/min/100g),Perfusion(ml/min/100g),Mean Transit Time(sec),Blood Volume (ml/100g),Positive Enhancement Integral(Hus).
Measured: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
Secondary outcomes (2)
Objective tumour response (RECIST )Progression free survival
Measured: RECIST scans within 4 weeks prior to first dose then 8 weekly up to 24 weeks, then 12 weekly thereafter
Baseline and on treatment time-point measurements for iAUC60 (mMol/sec) and Positive Enhancement Integral (Hus)
Measured: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust
- Investigators
- Jane Robertson, MD, Study director, AstraZeneca, Alderley ParkJohann De Bono, MD, Principal investigator, Institute of Cancer Research, Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748891
- Sponsor's protocol ID
- D1330C00003
- Other IDs
- EDRACT nbr 2007-006251-39
- Status last verified
- Jun 2011
- First submitted
- 5 Sep 2008
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Messiou C, Orton M, Ang JE, Collins DJ, Morgan VA, Mears D, Castellano I, Papadatos-Pastos D, Brunetto A, Tunariu N, Mann H, Tessier J, Young H, Ghiorghiu D, Marley S, Kaye SB, deBono JS, Leach MO, deSouza NM. Advanced solid tumors treated with cediranib: comparison of dynamic contrast-enhanced MR imaging and CT as markers of vascular activity. Radiology. 2012 Nov;265(2):426-36. doi: 10.1148/radiol.12112565. Epub 2012 Aug 13.
PubMed 22891356
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Open-Label, Non-randomised, Single Centre Methodology Study Comparing DCE-CT and DCE-MRI as Markers of Changes in Vascular Activity Mediated by a Positive Control Agent [Cediranib (Recentin™; AZD2171), a Potent Inhibitor of VEGF-driven Angiogenesis] in Patients With Advanced Solid Tumour
- ClinicalTrials.gov ID
- NCT00748891
- Acronym / sponsor ID
- D1330C00003
- Conditions
- Cancer
- Keywords
- Cancer, tumour, advanced sold tumour, imaging, DCE-CT Scan, DCE-MRI scan, Cediranib, Recentin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Sep 2008 (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 being carried out in patients with advanced solid tumours to assess which of two different types of imaging scans best measures activity of an experimental drug called Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most accurate and best predicts a response to the treatment. Cediranib is thought to work by stopping blood flow to cancers, and both of these scans assess blood flow. Studying the response of cancers by measuring changes in their blood flow may provide useful information that will guide the way we manage cancers in the future.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Recentin (Cediranib)Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression |
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 confirmed metastatic tumour which is refractory to standard therapies
- At least one lesion size ≥3cm on in longest diameter suitable for repeat assessment by DCE-CT and DCE-MRI
- Patients must be able to undergo DCE-CT and DCE-MRI scanning procedures
- Life expectancy of at least 12 weeks
Key exclusion criteria (3 listed)
- Patients with hormone refractory prostate cancer (HRPC)
- Patients with a history of poorly controlled high blood pressure
- Ineligibility for MRI scanning or DCE-CT or DCE-MRI scanning
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 |
|---|---|---|
| Recentin (Cediranib)Also: Cediranib30mg once daily, oral dose | Drug | 1 |
Primary outcome
Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities.
Time frame: DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1.
Baseline measurements for DCE-MRI-iAUC60(mMol/sec),Ktrans(min-1),ve,vp,kep(min-1,Enhancing Fraction% DCE-CT-Permeability Surface Product(ml/min/100g),Perfusion(ml/min/100g),Mean Transit Time(sec),Blood Volume (ml/100g),Positive Enhancement Integral(Hus).
Time frame: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
2 secondary outcomes
Objective tumour response (RECIST )Progression free survival
Time frame: RECIST scans within 4 weeks prior to first dose then 8 weekly up to 24 weeks, then 12 weekly thereafter
Baseline and on treatment time-point measurements for iAUC60 (mMol/sec) and Positive Enhancement Integral (Hus)
Time frame: DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28
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 1 Jul 2011.
- Derived from this study: PubMed 22891356Messiou C, Orton M, Ang JE, Collins DJ, Morgan VA, Mears D, Castellano I, Papadatos-Pastos D, Brunetto A, Tunariu N, Mann H, Tessier J, Young H, Ghiorghiu D, Marley S, Kaye SB, deBono JS, Leach MO, deSouza NM. Advanced solid tumors treated with cediranib: comparison of dynamic contrast-enhanced MR imaging and CT as markers of vascular activity. Radiology. 2012 Nov;265(2):426-36. doi: 10.1148/radiol.12112565. Epub 2012 Aug 13.
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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.
Jane Robertson, MD study director
AstraZeneca, Alderley Park
Johann De Bono, MD principal investigator
Institute of Cancer Research, Royal Marsden Hospital
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 Recentin (Cediranib) in people with Cancer, run by AstraZeneca 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 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 1 Jul 2011. 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 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?
Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities. (time frame: DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748891, which also lists 1 linked publication.
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 1 Jul 2011.