TumorsPhase 2NCT00264004

Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

A Phase 2 study testing AZD2171 in people with Tumors, run by AstraZeneca at 6 sites in 3 countries.

Completed

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

Trial summary

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tumors
What is being tested?: AZD2171
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 6 sitesin 3 countries
Study dates: Nov 2005to Apr 2011
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

Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Who cannot join

Prior treatment with a VEGF inhibitor
Poorly controlled hypertension

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

Netherlands3 sites

Research Site
Amsterdam
Research Site
Nijmegen
Research Site
Utrecht

Other trials in Netherlands

Germany2 sites

Research Site
Freiburg im Breisgau
Research Site
Hamburg

Other trials in Germany

United Kingdom1 site

Research Site
Surrey

Other trials in United Kingdom

About this study

Official title: A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients With Advanced Solid Tumours

Conditions: Tumors
Being tested: AZD2171
Keywords: Advanced Solid Tumours, phase II, Hypertension, RECENTIN
Medical subject headings: Neoplasms, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2171Drug
Also called Cediranib, RECENTIN™
30 mg \& 45 mg oral tablet

Study groups in NCT00264004
Study group	Role	What they receive
1	Experimental	30 mg AZD2171 Receives: Drug: AZD2171
2	Experimental	45 mg AZD2171 Receives: Drug: AZD2171

What is being measured

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

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
Measured: 12 week treatment period
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)
Measured: 12 week treatment period

Secondary outcomes (3)

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
Measured: First 6 weeks of 12 week treatment period
Objective Response Rate
Number of patients with complete or partial response (CR/PR), based on RECIST
Measured: 12 week treatment period
Best Percentage Change in Tumour Size
Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.
Measured: Randomisation until end of treatment period

Timeline

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

Nov 2005Apr 2011

First posted12 Dec 2005 (estimated)
Study startNov 2005
Primary completionJan 2007
Study completionApr 2011

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00264004
Sponsor's protocol ID: D8480C00038
Other IDs: EUDRACT Number 2005-003442-33
Status last verified: Jul 2012
First submitted: 9 Dec 2005
Last updated: 29 Aug 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?

See locations

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All Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT00264004
Acronym / sponsor ID: D8480C00038
Conditions: Tumors
Keywords: Advanced Solid Tumours, phase II, Hypertension, RECENTIN
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Jan 2007 (actual)
Study completion: Apr 2011 (actual)
First posted: 12 Dec 2005 (estimated)
Results: Posted 29 Aug 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: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD217130 mg AZD2171
2	Experimental	Drug: AZD217145 mg AZD2171

Who may qualify

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

Key inclusion criteria (1 listed)

Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Key exclusion criteria (2 listed)

Prior treatment with a VEGF inhibitor
Poorly controlled hypertension

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
AZD2171Also: Cediranib, RECENTIN™30 mg \& 45 mg oral tablet	Drug	1, 2

Primary outcome

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171
Time frame: 12 week treatment period
Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171
Time frame: 12 week treatment period
Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

3 secondary outcomes

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171
Time frame: First 6 weeks of 12 week treatment period
Objective Response Rate
Time frame: 12 week treatment period
Best Percentage Change in Tumour Size
Time frame: Randomisation until end of treatment period

Results and safety

Results posted to the registry on 29 Aug 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
AZD2171 30 mg Anti HT	30	13
AZD2171 30 mg No Anti HT	32	21
AZD2171 45 mg Anti HT	30	16
AZD2171 45 mg No Anti HT	34	19

Primary outcome: Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171

Time frame: 12 week treatment period. Number. Unit: Participants

Measure	AZD2171 30 mg Anti HT n = 30	AZD2171 30 mg No Anti HT n = 32	AZD2171 45 mg Anti HT n = 30	AZD2171 45 mg No Anti HT n = 34
Value	12	19	20	24

Primary outcome: Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

Time frame: 12 week treatment period. Median (90% Confidence Interval). Unit: Poportion of Planned Dose

Measure	AZD2171 30 mg Anti HT n = 30	AZD2171 30 mg No Anti HT n = 32	AZD2171 45 mg Anti HT n = 30	AZD2171 45 mg No Anti HT n = 34
Value	0.89 (0.62 to 1.00)	0.88 (0.76 to 0.98)	0.74 (0.58 to .91)	0.79 (0.64 to 0.87)

3 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
AZD2171 30 mg Anti HT	19 of 28 (67.9%)	31 of 28 (110.7%)	Not reported
AZD2171 30 mg No Anti HT	20 of 31 (64.5%)	34 of 31 (109.7%)	Not reported
AZD2171 45 mg Anti HT	10 of 26 (38.5%)	27 of 26 (103.8%)	Not reported
AZD2171 45 mg No Anti HT	10 of 34 (29.4%)	26 of 34 (76.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tumors

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

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

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2171 in people with Tumors, run by AstraZeneca at 6 sites in 3 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 1 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 29 Aug 2012. 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 Netherlands, Germany, 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 29 Aug 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?

Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 (time frame: 12 week treatment period). 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 NCT00264004.

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 29 Aug 2012.