Advanced Solid MalignanciesPhase 1NCT00981721
A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies
A Phase 1 study testing cediranib (RECENTIN TM, AZD2171) in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in China.
Trial summary
This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- cediranib (RECENTIN TM, AZD2171)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2009to Apr 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
- Provision of informed consent
- Histological and/or cytological confirmed advanced solid malignancies
- Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist
Who cannot join
- For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
- Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
- Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Research Site
Beijing, Beijing Municipality
Research Site
Hong Kong, Hong Kong
About this study
Official title: A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies
This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.
The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.
- Conditions
- Advanced Solid Malignancies
- Being tested
- cediranib (RECENTIN TM, AZD2171)
- Keywords
- Phase I, Advanced solid malignancies, Advanced solid tumour, Advanced cancer, Cediranib (RECENTIN™, AZD2171), China, PK, pharmacokinetics
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 or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | cediranib 20mg Receives: Drug: cediranib (RECENTIN TM, AZD2171) |
| 2 | Experimental | cediranib 30mg 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 pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours
Measured: Multiple assessments in the first 6 days
Secondary outcomes (2)
To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours
Measured: Multiple assessments up to day 29
To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.
Measured: Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeannie Hou, Study director, AstraZeneca China MCSun Yan, Prof, Principal investigator, Cancer Hospital, CAMS&PUMC, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981721
- Sponsor's protocol ID
- D8480C00060
- Status last verified
- Jun 2011
- First submitted
- 21 Sep 2009
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00981721
- Acronym / sponsor ID
- D8480C00060
- Conditions
- Advanced Solid Malignancies
- Keywords
- Phase I, Advanced solid malignancies, Advanced solid tumour, Advanced cancer, Cediranib (RECENTIN™, AZD2171), China, PK, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Sep 2009 (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 to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.
The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cediranib (RECENTIN TM, AZD2171)cediranib 20mg |
| 2 | Experimental | Drug: cediranib (RECENTIN TM, AZD2171)cediranib 30mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- Histological and/or cytological confirmed advanced solid malignancies
- Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist
Key exclusion criteria (3 listed)
- For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
- Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
- Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.
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 or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8 | Drug | 1, 2 |
Primary outcome
To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours
Time frame: Multiple assessments in the first 6 days
2 secondary outcomes
To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours
Time frame: Multiple assessments up to day 29
To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.
Time frame: Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up
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 20 Jun 2011.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
Jeannie Hou study director
AstraZeneca China MC
Sun Yan, Prof principal investigator
Cancer Hospital, CAMS&PUMC, China
2 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 cediranib (RECENTIN TM, AZD2171) in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in China.
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 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 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours (time frame: Multiple assessments in the first 6 days). 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 20 Jun 2011.