A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

June 15, 2012 updated by: Pfizer

A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Pfizer Investigational Site
      • Salzburg, Austria, A-5020
        • Pfizer Investigational Site
      • Wels, Austria, A-4600
        • Pfizer Investigational Site
  • Belgium
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
      • Namur, Belgium, 5000
        • Pfizer Investigational Site
      • Turnhout, Belgium, 2300
        • Pfizer Investigational Site
      • Yvoir, Belgium, 5530
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Pfizer Investigational Site
      • Calgary, Alberta, Canada, T2S 3C3
        • Pfizer Investigational Site
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1M5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2W 1T8
        • Pfizer Investigational Site
  • Czech Republic
      • Praha 4, Czech Republic, 140 59
        • Pfizer Investigational Site
      • Praha 5, Czech Republic, 150 06
        • Pfizer Investigational Site
      • Praha 5, Czech Republic, 15006
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9100
        • Pfizer Investigational Site
      • Koebenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
      • Odense, Denmark, 5000
        • Pfizer Investigational Site
  • France
      • Angers cedex 01, France, 49033
        • Pfizer Investigational Site
      • BORDEAUX Cedex, France, 33076
        • Pfizer Investigational Site
      • CAEN Cedex 5, France, 14076
        • Pfizer Investigational Site
      • Lyon, France, Cedex 08
        • Pfizer Investigational Site
      • Nancy, France, 54100
        • Pfizer Investigational Site
      • Paris, France, 75231
        • Pfizer Investigational Site
    • Cedex 05
      • Montpellier, Cedex 05, France, 34059
        • Pfizer Investigational Site
  • Germany
      • Erlangen, Germany, 91054
        • Pfizer Investigational Site
      • Frankenthal, Germany, 67227
        • Pfizer Investigational Site
      • Frankfurt am Main, Germany, 60590
        • Pfizer Investigational Site
      • Fuerstenwalde, Germany, 15517
        • Pfizer Investigational Site
      • Goettingen, Germany, 37099
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
      • Nuernberg, Germany, 90419
        • Pfizer Investigational Site
      • Stendal, Germany, 39576
        • Pfizer Investigational Site
      • Ulm, Germany, 89075
        • Pfizer Investigational Site
      • Voelklingen, Germany, 66333
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 18547
        • Pfizer Investigational Site
      • Ioannina, Greece, 45 110
        • Pfizer Investigational Site
      • Patras, Greece, 26500
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 564 03
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71 110
        • Pfizer Investigational Site
  • Ireland
      • Dublin, Ireland, 4
        • Pfizer Investigational Site
      • Dublin, Ireland, 7
        • Pfizer Investigational Site
      • Dublin, Ireland, 8
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Brescia, Italy, 25123
        • Pfizer Investigational Site
      • Messina, Italy, 98122
        • Pfizer Investigational Site
      • Milano, Italy, 20148
        • Pfizer Investigational Site
      • Palermo, Italy, 90127
        • Pfizer Investigational Site
      • Parma, Italy, 43100
        • Pfizer Investigational Site
      • Roma, Italy, 00144
        • Pfizer Investigational Site
      • Roma, Italy, 00133
        • Pfizer Investigational Site
      • Saronno (VA), Italy, 21047
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site
      • Sittard-geleen, Netherlands, 6162 BG
        • Pfizer Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • Pfizer Investigational Site
  • Norway
      • Levanger, Norway, 7600
        • Pfizer Investigational Site
      • Oslo, Norway, 0407
        • Pfizer Investigational Site
  • Poland
      • Lodz, Poland, 93-509
        • Pfizer Investigational Site
      • Lublin, Poland, 20-090
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Pfizer Investigational Site
    • Sector 2
      • Bucuresti, Sector 2, Romania, 022328
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 143423
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 191104
        • Pfizer Investigational Site
    • Leningrad region
      • Kuzmolovo, Vsevolozhsk district, Leningrad region, Russian Federation, 188663
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Burgos, Spain, 09005
        • Pfizer Investigational Site
      • Cadiz, Spain, 11009
        • Pfizer Investigational Site
      • La Coruña, Spain, 15009
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Sevilla, Spain, 41020
        • Pfizer Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Pfizer Investigational Site
      • Essex, United Kingdom, CM16 6TN
        • Pfizer Investigational Site
      • London, United Kingdom, W6 8RF
        • Pfizer Investigational Site
      • Swansea, United Kingdom, SA2 8QA
        • Pfizer Investigational Site
      • Truro, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
      • Worthing, United Kingdom, BN11 2DH
        • Pfizer Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7WE
        • Pfizer Investigational Site
      • Harlow, Essex, United Kingdom, CM20 1QX
        • Pfizer Investigational Site
    • Staffordshire
      • Burton upon Trent, Staffordshire, United Kingdom, DE13 0RB
        • Pfizer Investigational Site
    • West Sussex
      • Worthing, West Sussex, United Kingdom, BN11 2DH
        • Pfizer Investigational Site
  • United States
    • California
      • Downey, California, United States, 90241
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Montebello, California, United States, 90640
        • Pfizer Investigational Site
      • Whittier, California, United States, 90606
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Pfizer Investigational Site
      • Boynton Beach, Florida, United States, 33437
        • Pfizer Investigational Site
      • Coral Springs, Florida, United States, 33065
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States, 33467
        • Pfizer Investigational Site
      • Lakeland, Florida, United States, 33805
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33125
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33129
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33133
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Pfizer Investigational Site
    • Georgia
      • Duluth, Georgia, United States, 30096
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • Pfizer Investigational Site
      • Snellville, Georgia, United States, 30078
        • Pfizer Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
      • Mooresville, Indiana, United States, 46158
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pfizer Investigational Site
      • Gretna, Louisiana, United States, 70056
        • Pfizer Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Pfizer Investigational Site
    • Maryland
      • Kensington, Maryland, United States, 20895
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20850
        • Pfizer Investigational Site
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28262
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28277
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Clairton, Pennsylvania, United States, 15025
        • Pfizer Investigational Site
      • Greensburg, Pennsylvania, United States, 15601
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pfizer Investigational Site
      • Pottstown, Pennsylvania, United States, 19464
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, United States, 15090
        • Pfizer Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
      • Smyrna, Tennessee, United States, 37167
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78745
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78757
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78759
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Corpus Christi, Texas, United States, 78405
        • Pfizer Investigational Site
      • Corpus Christi, Texas, United States, 78410
        • Pfizer Investigational Site
      • Georgetown, Texas, United States, 78626
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Layton, Utah, United States, 84041
        • Pfizer Investigational Site
      • Murray, Utah, United States, 84157
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
      • West Provo, Utah, United States, 84604
        • Pfizer Investigational Site
      • West Valley City, Utah, United States, 84120
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23298-0037
        • Pfizer Investigational Site
    • Washington
      • Kennewick, Washington, United States, 99336
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
  • Previous treatment with an anthracycline and a taxane in any setting
  • Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

  • History of inflammatory carcinoma if there is no other measurable disease
  • More than 2 chemotherapy agents in the advanced disease setting
  • Brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: B
Drug: Capecitabine
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
Experimental: A
Drug: Sunitinib + Capecitabine

Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.

Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Baseline until disease progression (up to 3 years from first dose)
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
Baseline until disease progression (up to 3 years from first dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response (OR)
Time Frame: Baseline until response or disease progression (up to 3 years from first dose)
Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.
Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
Time Frame: Baseline until response or disease progression (up to 3 years from first dose)
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.
Baseline until response or disease progression (up to 3 years from first dose)
Overall Survival (OS)
Time Frame: Baseline until death or up to 3 years from first dose
Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.
Baseline until death or up to 3 years from first dose
Percent Chance of Participant Survival
Time Frame: Year 1, Year 2, Year 3
Probability of survival 2 years and 3 years after the first dose of study treatment.
Year 1, Year 2, Year 3
Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms
Day 1 of each treatment cycle (up to 3 years or end of treatment)
Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)
Time Frame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
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 = greater degree of symptoms.
Day 1 of each treatment cycle (up to 3 years or end of treatment)
Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)
Time Frame: Day 1 of each treatment cycle (up to 3 years or end of treatment)
EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Day 1 of each treatment cycle (up to 3 years or end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6181099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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