Solid TumorsPhase 1NCT00750841
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
A Phase 1 study testing cediranib in people with Solid Tumors, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- cediranib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Sep 2008to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
- Estimated life expectancy of at least 8 weeks
- WHO performance status (PS) 0-2.
Who cannot join
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom4 sites
Research Site
Dundee, DD1 9SY
Research Site
Glasgow, G12 0YN
Research Site
London, NW1 2PG
Research Site
London, SE1 9RT
Canada2 sites
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Montreal, Quebec, H3T 1E2
About this study
Official title: A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours
Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.
- Conditions
- Solid Tumors
- Being tested
- cediranib
- Keywords
- advanced cancer, metastatic, rifampicin, pharmacokinetics, Phase I, Advanced solid tumours
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cediranibDrug
Also called RECENTIN
45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone. Receives: Drug: cediranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin
Measured: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.
Secondary outcomes (1)
To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram.
Measured: Until study drug is discountinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study start9 Sep 2008
- Primary completion30 Jul 2009
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Sawyer, MD, Principal investigator, Cross Cancer Institute, Edmonton, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750841
- Sponsor's protocol ID
- D8480C00029
- Other IDs
- 2008-002519-42, 2008
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2008
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00750841
- Acronym / sponsor ID
- D8480C00029
- Conditions
- Solid Tumors
- Keywords
- advanced cancer, metastatic, rifampicin, pharmacokinetics, Phase I, Advanced solid tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2008 (actual)
- Primary completion
- 30 Jul 2009 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 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.
Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cediranibCediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
- Estimated life expectancy of at least 8 weeks
- WHO performance status (PS) 0-2.
Key exclusion criteria (4 listed)
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
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 |
|---|---|---|
| cediranibAlso: RECENTIN45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce. | Drug | 1 |
Primary outcome
To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin
Time frame: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.
1 secondary outcome
To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram.
Time frame: Until study drug is discountinued
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- CSR-D8480C00029.pdfLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Related trials for Solid Tumors
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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.
Michael Sawyer, MD principal investigator
Cross Cancer Institute, Edmonton, AB, Canada
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cediranib in people with Solid Tumors, run by AstraZeneca at 6 sites in 2 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin (time frame: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.). 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 17 Aug 2026.