Advanced Solid TumorsPhase 1NCT00750425
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
A Phase 1 study testing cediranib (RECENTIN TM, AZD2171) in people with Advanced Solid Tumors, run by AstraZeneca at 5 sites in 2 countries.
Trial summary
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- cediranib (RECENTIN TM, AZD2171)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2008to Jan 2011
- 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
- Written informed consent
- Histological or cytological confirmation of advanced solid tumour (with the exception of 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
5 sites in 2 countries.
5 sites in 2 countries
Canada3 sites
Research Site
Hamilton
Research Site
Toronto
Research Site
Vancouver
About this study
Official title: A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
- Conditions
- Advanced Solid Tumors
- Being tested
- cediranib (RECENTIN TM, AZD2171)
- Keywords
- advanced cancer,, metastatic, ketoconazole, pharmacokinetics, Phase I
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cediranib (RECENTIN TM, AZD2171)Drug
20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone Receives: Drug: cediranib (RECENTIN TM, AZD2171) |
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 ketoconazole.
Measured: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Secondary outcomes (1)
Safety and tolerability of cediranib in the presence of ketoconazole 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 posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jane Roberston, Study director, AstraZeneca Aderley ParkDr U Lassen, MD PhD, Principal investigator, The Finsen Center, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750425
- Sponsor's protocol ID
- D8480C00020
- Other IDs
- EUDRACT number 2008-002271-27
- Status last verified
- Mar 2011
- First submitted
- 8 Sep 2008
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. 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 Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00750425
- Acronym / sponsor ID
- D8480C00020
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced cancer,, metastatic, ketoconazole, pharmacokinetics, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 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 ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cediranib (RECENTIN TM, AZD2171)Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Histological or cytological confirmation of advanced solid tumour (with the exception of 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 |
|---|---|---|
| cediranib (RECENTIN TM, AZD2171)20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days) | Drug | 1 |
Primary outcome
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Time frame: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
1 secondary outcome
Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
Time frame: Until study drug is discountinued
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 10 Mar 2011.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 Roberston study director
AstraZeneca Aderley Park
Dr U Lassen, MD PhD principal investigator
The Finsen Center, Copenhagen, Denmark
5 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 (RECENTIN TM, AZD2171) in people with Advanced Solid Tumors, run by AstraZeneca at 5 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: finished, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Denmark. 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?
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole. (time frame: PK assessments to be taken until Day 42. Days 7 and 10 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 10 Mar 2011.