CancerPhase 2NCT00306891

Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

A Phase 2 study testing Cediranib and Cediranib 30 - 90 mg in people with Cancer, run by AstraZeneca at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: Cediranib and Cediranib 30 - 90 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 4 sitesUnited Kingdom
Study dates: Jun 2006to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Clinical diagnosis of advanced solid tumour.
Ability to eat a high fat breakfast

Who cannot join

Poorly controlled high blood pressure.
History of significant gastrointestinal problems

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

Research Site
Glasgow
Research Site
Headington
Research Site
London
Research Site
Manchester

Other trials in United Kingdom

About this study

Official title: Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing

Conditions: Cancer
Being tested: Cediranib, Cediranib 30 - 90 mg
Keywords: Advanced solid tumours, Advanced cancer, tumor, tumour, RECENTIN
Medical subject headings: Neoplasms

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 oral dose
Cediranib 30 - 90 mgDrug
Also called RECENTIN™
oral tablet dose escalation

Study groups in NCT00306891
Study group	Role	What they receive
Cediranib 45 mg Fed	Experimental	Part A: Cediranib 45 mg Fed State Receives: Drug: Cediranib
Cediranib 45 mg Fasted	Experimental	Part A: Cediranib 45 mg Fasted State Receives: Drug: Cediranib
Cediranib 45 mg Fixed Dose	Experimental	Part B: Cediranib 45 mg Fixed Dose Receives: Drug: Cediranib
Cediranib 30 - 90 mg Dose Escalation	Experimental	Part B: Cediranib 30 - 90 mg Dose Escalation Receives: Drug: Cediranib 30 - 90 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Area Under Plasma Concentration-time Curve (AUC)
Area under plasma concentration-time curve from zero to infinity
Measured: Measurements were collected up to 168 hours (following single dosing).
Part A: Maximum Plasma (Peak) Concentration (Cmax)
Maximum plasma drug concentration
Measured: Measurements were collected up to 168 hours (following single dosing).

Secondary outcomes (6)

Part A: AUC (0-t)
Area under the curve from time 0 to the last measureable time point
Measured: Measurements were collected up to 168 hours (following single dosing).
Part A: Time to Peak or Maximum Concentration (Tmax)
Time to reach peak or maximum concentration or maximum response
Measured: Measurements were collected up to 168 hours (following single dosing).
Part A: Terminal Phase Half-life (t1/2λz)
Terminal phase half-life
Measured: Measurements were collected up to 168 hours (following single dosing).
Part A: Apparent Total Body Clearance (CL/F)
Apparent total body clearance of drug from plasma
Measured: Measurements were collected up to 168 hours (following single dosing).
Part B: Best Overall Response Rate (ORR)
Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.
Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions
Measured: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.
Part B: Progression-free Survival (PFS)
Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).
Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.
Progression (PD) Unequivocal progression of existing non-target lesions.
Measured: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Sep 2008

First posted27 Mar 2006 (estimated)
Study startJun 2006
Primary completionJan 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00306891
Sponsor's protocol ID: D8480C00021
Other IDs: 2005-003441-13, 2005
Status last verified: Oct 2012
First submitted: 23 Mar 2006
Last updated: 1 Nov 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing
ClinicalTrials.gov ID: NCT00306891
Acronym / sponsor ID: D8480C00021
Conditions: Cancer
Keywords: Advanced solid tumours, Advanced cancer, tumor, tumour, RECENTIN
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jan 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 27 Mar 2006 (estimated)
Results: Posted 1 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cediranib 45 mg Fed	Experimental	Drug: CediranibPart A: Cediranib 45 mg Fed State
Cediranib 45 mg Fasted	Experimental	Drug: CediranibPart A: Cediranib 45 mg Fasted State
Cediranib 45 mg Fixed Dose	Experimental	Drug: CediranibPart B: Cediranib 45 mg Fixed Dose
Cediranib 30 - 90 mg Dose Escalation	Experimental	Drug: Cediranib 30 - 90 mgPart B: Cediranib 30 - 90 mg Dose Escalation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of advanced solid tumour.
Ability to eat a high fat breakfast

Key exclusion criteria (2 listed)

Poorly controlled high blood pressure.
History of significant gastrointestinal problems

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: RECENTIN™45 mg oral dose	Drug	Cediranib 45 mg Fasted, Cediranib 45 mg Fed, Cediranib 45 mg Fixed Dose
Cediranib 30 - 90 mgAlso: RECENTIN™oral tablet dose escalation	Drug	Cediranib 30 - 90 mg Dose Escalation

Primary outcome

Part A: Area Under Plasma Concentration-time Curve (AUC)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Area under plasma concentration-time curve from zero to infinity
Part A: Maximum Plasma (Peak) Concentration (Cmax)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Maximum plasma drug concentration

6 secondary outcomes

Part A: AUC (0-t)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Time to Peak or Maximum Concentration (Tmax)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Terminal Phase Half-life (t1/2λz)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Apparent Total Body Clearance (CL/F)
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part B: Best Overall Response Rate (ORR)
Time frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.
Part B: Progression-free Survival (PFS)
Time frame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Results and safety

Results posted to the registry on 1 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cediranib 45 mg Fed	23	18
Cediranib 45 mg Fasted	22	16
Cediranib 45 mg Fixed Dose	0	0
Cediranib 30 to 90 mg Dose Escalation	0	0

Primary outcome: Part A: Area Under Plasma Concentration-time Curve (AUC)

Time frame: Measurements were collected up to 168 hours (following single dosing).. Geometric mean (Full Range). Unit: ng*h/mL

Measure	Cediranib 45 mg Fed n = 30	Cediranib 45 mg Fasted n = 32
Value	1920 (778 to 5760)	2392 (604 to 5730)

Primary outcome: Part A: Maximum Plasma (Peak) Concentration (Cmax)

Time frame: Measurements were collected up to 168 hours (following single dosing).. Geometric mean (Full Range). Unit: ng/mL

Measure	Arm 1 - Cediranib 45 mg Fed n = 31	Arm 2 - Cediranib 45 mg Fasted n = 33
Value	87.02 (27.6 to 265)	127.9 (35.6 to 334)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cediranib 45 mg Part A	6 of 39 (15.4%)	34 of 39 (87.2%)	Not reported
Cediranib 45 mg Fixed Dose	9 of 16 (56.3%)	16 of 16 (100%)	Not reported
Cediranib 30 - 90 mg Dose Escalation	20 of 31 (64.5%)	31 of 31 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

AstraZeneca AZD2171 Medical Science Director, MD study director

AstraZeneca

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cediranib and Cediranib 30 - 90 mg in people with Cancer, run by AstraZeneca at 4 sites 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 2 inclusion and 2 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part A: Area Under Plasma Concentration-time Curve (AUC) (time frame: Measurements were collected up to 168 hours (following single dosing).). 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 NCT00306891.

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 Nov 2012.