Breast NeoplasmsPhase 3NCT00373113

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

A Phase 3 study testing Capecitabine and Sunitinib malate in people with Breast Neoplasms, run by Pfizer at 123 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Capecitabine and Sunitinib malate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 482 participants
Where: 123 sitesin 23 countries
Study dates: Nov 2006to Jun 2011
Phase: Phase 3
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

breast adenocarcinoma
prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Who cannot join

Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
Any prior regimen with capecitabine

Trial locations and contacts

123 sites in 23 countries.

Country

City, postcode or hospital

123 sites in 23 countries

Spain14 sites

Pfizer Investigational Site
A Coruña, La Coruña, 15006
Pfizer Investigational Site
Alcorcón, Madrid, 28922
Pfizer Investigational Site
Bilbao, Vizcaya, 48013
Pfizer Investigational Site
Córdoba, Cordoba, 14004
Pfizer Investigational Site
Girona, Gerona, 17007
Pfizer Investigational Site
Jaén, Jaen, 23007
Pfizer Investigational Site
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016
Pfizer Investigational Site
Madrid, Madrid, 28033
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Mataró, Barcelona, 08304
Pfizer Investigational Site
Sabadell, Barcelona, 08208
Pfizer Investigational Site
Salamanca, Salamanca, 37007
Pfizer Investigational Site
Santander, Cantabria, 39008

Other trials in Spain

Germany13 sites

Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
Frankfurt, 60488
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Jena, 07743
Pfizer Investigational Site
Kiel, 24103
Pfizer Investigational Site
Leer, 26789
Pfizer Investigational Site
Lübeck, 23538
Pfizer Investigational Site
Magdeburg, 39130
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
Meiningen, 98617
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Offenburg, 77652
Pfizer Investigational Site
Tübingen, 72076

Other trials in Germany

Japan9 sites

Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chuo-Ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Kita-adachi-gun, Saitama
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Matsuyama, Ehime
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Suita, Osaka

Other trials in Japan

Argentina7 sites

Pfizer Investigational Site
Bahía Blanca, Prov. de Buenos Aires, B8001HXM
Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Buenos Aires, C1405BCH
Pfizer Investigational Site
Córdoba, Córdoba Province, X5000AAI
Pfizer Investigational Site
Rosario, Santa Fe Province, (2000)
Pfizer Investigational Site
San Miguel de Tucumán, T4000IAK
Pfizer Investigational Site
Viedma, Río Negro Province, 8500

Other trials in Argentina

France7 sites

Pfizer Investigational Site
Bayonne, 64100
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Clermont-Ferrand, 63011
Pfizer Investigational Site
Lille, 59020 Cedex
Pfizer Investigational Site
Neuilly-sur-Seine, 92200
Pfizer Investigational Site
Nice, 06100
Pfizer Investigational Site
Rennes, 35042

Other trials in France

Mexico7 sites

Pfizer Investigational Site
Acapulco de Juárez, Guerrero, 39670
Pfizer Investigational Site
Chihuahua City, Chihuahua, 31000
Pfizer Investigational Site
Ciudad Obregón, Sonora, 85000
Pfizer Investigational Site
Mexico City, Mexico City, 11000
Pfizer Investigational Site
Morelia, Michoacán, 58020
Pfizer Investigational Site
Puebla City, Puebla, 72530
Pfizer Investigational Site
Toluca, State of Mexico, 50180

Other trials in Mexico

Taiwan7 sites

Pfizer Investigational Site
Changhua, 500
Pfizer Investigational Site
Kaohsiung City, 807
Pfizer Investigational Site
Tainan, 704
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 106
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taoyuan, 333

Other trials in Taiwan

Australia6 sites

Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Parkville, Victoria, 3050
Pfizer Investigational Site
Perth, Western Australia, 6000

Other trials in Australia

Brazil6 sites

Pfizer Investigational Site
Curitiba, Paraná, 80530-010
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 91350-200
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20560-120
Pfizer Investigational Site
São Paulo, São Paulo, 01246-000
Pfizer Investigational Site
São Paulo, São Paulo, 01509-900

Other trials in Brazil

Canada6 sites

Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
London, Ontario, N6A 4L6
Pfizer Investigational Site
Québec, Quebec, G1S 4L8
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5

Other trials in Canada

India5 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 078
Pfizer Investigational Site
Jaipur, Rajasthan, 302013
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226003
Pfizer Investigational Site
Ludhiana, Punjab, 141 008
Pfizer Investigational Site
Navrangpura / Ahmedabad, Gujarat, 380 009

Other trials in India

South Korea5 sites

Pfizer Investigational Site
Daegu, 705-717
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, 410-769
Pfizer Investigational Site
Incheon, 400-711
Pfizer Investigational Site
Pusan, 602-739
Pfizer Investigational Site
Seoul, 110-744

Other trials in South Korea

Bulgaria4 sites

Pfizer Investigational Site
Sofia, Bulgaria, 1756
Pfizer Investigational Site
Sofia, 1233
Pfizer Investigational Site
Sofia, 1527
Pfizer Investigational Site
Stara Zagora, 6000

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Hong Kong4 sites

Pfizer Investigational Site
Hong Kong
Pfizer Investigational Site
Kowloon
Pfizer Investigational Site
Tuenmen
Pfizer Investigational Site
Wan Chai

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Italy4 sites

Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Milan, 20162
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Reggio Emilia, 42100

Other trials in Italy

Philippines4 sites

Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Quezon City, 1102
Pfizer Investigational Site
Quezon City, 1104
Pfizer Investigational Site
San Juan City, 1000

Other trials in Philippines

United Kingdom4 sites

Pfizer Investigational Site
Cardiff, South Wales, CF14 2TL
Pfizer Investigational Site
London, SE1 9RT
Pfizer Investigational Site
Nottingham, NG5 1PB
Pfizer Investigational Site
Somerset, BA21 4AT

Other trials in United Kingdom

Colombia2 sites

Pfizer Investigational Site
Bogotá, Cundinamarca
Pfizer Investigational Site
Medellín, Antioquia

Other trials in Colombia

Peru2 sites

Pfizer Investigational Site
Lima, Lima Province, 05127
Pfizer Investigational Site
Lima, L 27

Other trials in Peru

Singapore2 sites

Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 169610

Other trials in Singapore

South Africa2 sites

Pfizer Investigational Site
Parktown, 2193
Pfizer Investigational Site
Sandton, 2199

Other trials in South Africa

Turkey (Türkiye)2 sites

Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Istanbul, 34390

Other trials in Turkey (Türkiye)

Chile1 site

Pfizer Investigational Site
Temuco, Araucania, 4810469

Other trials in Chile

About this study

Official title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

Read the detailed description

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Conditions: Breast Neoplasms
Being tested: Capecitabine, Sunitinib malate
Keywords: advanced breast cancer, metastatic breast cancer, treatment resistant, treatment failure
Medical subject headings: Breast Neoplasms

What participants receive

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

CapecitabineDrug
Also called xeloda
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Sunitinib malateDrug
Also called sunitinib
37.5 mg daily, continuous dosing

Study groups in NCT00373113
Study group	Role	What they receive
A	Active comparator	1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles Receives: Drug: Capecitabine
B	Experimental	37.5 mg daily, continuous dosing Receives: Drug: Sunitinib malate

What is being measured

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

Progression-Free Survival (PFS)
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
Measured: From time of randomization to every 6 weeks thereafter through 22 months or until death

Secondary outcomes (7)

Time to Tumor Progression (TTP)
Time from randomization to first documentation of objective tumor progression.
Measured: From time of randomization to every 6 weeks thereafter through 22 months
Number of Participants With Overall Response (OR)
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: From time of randomization to every 6 weeks thereafter through 22 months
Duration of Response (DR)
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Measured: From time of randomization to every 6 weeks thereafter through 22 months or death
Time to Tumor Response (TTR)
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Measured: From time of randomization to every 6 weeks thereafter through 22 months
Overall Survival (OS)
Average time from randomization to first documentation of death due to any cause.
Measured: From time of randomization until death
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).
Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
Measured: From Day 1 of Cycle 1, then odd numbered cycles thereafter
EORTC QLQ Breast Cancer Module (BR23)
BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.
Measured: From Day 1 of Cycle 1, then odd numbered cycles thereafter

Timeline

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

Nov 2006Jun 2011

First posted7 Sep 2006 (estimated)
Study startNov 2006
Primary completionOct 2009
Study completionJun 2011

Why it stopped: See termination reason in detailed description.

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 Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00373113
Sponsor's protocol ID: A6181107
Status last verified: Jun 2012
First submitted: 5 Sep 2006
Last updated: 25 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
ClinicalTrials.gov ID: NCT00373113
Acronym / sponsor ID: A6181107
Conditions: Breast Neoplasms
Keywords: advanced breast cancer, metastatic breast cancer, treatment resistant, treatment failure
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 482 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Oct 2009 (actual)
Study completion: Jun 2011 (actual)
First posted: 7 Sep 2006 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Capecitabine1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
B	Experimental	Drug: Sunitinib malate37.5 mg daily, continuous dosing

Who may qualify

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

Key inclusion criteria (2 listed)

breast adenocarcinoma
prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Key exclusion criteria (2 listed)

Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
Any prior regimen with capecitabine

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
CapecitabineAlso: xeloda1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles	Drug	A
Sunitinib malateAlso: sunitinib37.5 mg daily, continuous dosing	Drug	B

Primary outcome

Progression-Free Survival (PFS)
Time frame: From time of randomization to every 6 weeks thereafter through 22 months or until death
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.

7 secondary outcomes

Time to Tumor Progression (TTP)
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Number of Participants With Overall Response (OR)
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Duration of Response (DR)
Time frame: From time of randomization to every 6 weeks thereafter through 22 months or death
Time to Tumor Response (TTR)
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Overall Survival (OS)
Time frame: From time of randomization until death
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter
EORTC QLQ Breast Cancer Module (BR23)
Time frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib	238	0
Capecitabine	244	0

Primary outcome: Progression-Free Survival (PFS)

Time frame: From time of randomization to every 6 weeks thereafter through 22 months or until death. Median (95% Confidence Interval). Unit: Months

Measure	Sunitinib n = 238	Capecitabine n = 244
Value	2.8 (2.4 to 4.0)	4.2 (3.8 to 5.5)

Sunitinib vs Capecitabine: Hazard Ratio (HR): 1.470 (95% CI 1.156 to 1.869), p = 0.002, Log Rank

Population analysed: Intent-to-treat (ITT) population: included all participants who were randomized.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib	72 of 238 (30.3%)	228 of 238 (95.8%)	Not reported
Capecitabine	44 of 240 (18.3%)	229 of 240 (95.4%)	Not reported

Limitations and caveats (from the sponsor): Due to patient enrollment termination, PFS/OR/TTP/DR were done by investigator assessment due to lack of central review data and TTR/EORTC QLQ-C30/QLQ BR23 analyses were not done. Those enrolled could receive capecitabine or enter an extension trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Pfizer CT.gov Call Center study director

Pfizer

123 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine and Sunitinib malate in people with Breast Neoplasms, run by Pfizer at 123 sites in 23 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 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: stopped early, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in Spain, Germany, Japan, Argentina, France and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Nov 2010). 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?

Progression-Free Survival (PFS) (time frame: From time of randomization to every 6 weeks thereafter through 22 months or until death). 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 NCT00373113.

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 25 Jun 2012.