Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

March 10, 2015 updated by: Pfizer

International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

Study Overview

Status

Status

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

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.

Detailed Description

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

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.
828

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

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Pfizer Investigational Site
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • Queensland
      • Pimlico, Queensland, Australia, 4812
        • Pfizer Investigational Site
      • Townsville, Queensland, Australia, 4814
        • Pfizer Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • Pfizer Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Pfizer Investigational Site
      • Toorak Gardens, South Australia, Australia, 5065
        • Pfizer Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Pfizer Investigational Site
      • East Ringwood, Victoria, Australia, 3135
        • Pfizer Investigational Site
      • Wodonga, Victoria, Australia, 3690
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Belgium
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Liège, Belgium, 4000
        • Pfizer Investigational Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2A 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
      • Rimouski, Quebec, Canada, G5L 5T1
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100021
        • Pfizer Investigational Site
      • Beijing, China, 100071
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
    • Liaoning
      • Dalian, Xigang District, Liaoning, China, 116011
        • Pfizer Investigational Site
  • Cyprus
      • Nicosia, Cyprus, 2006
        • Pfizer Investigational Site
  • Czech Republic
      • Nova Ves Pod Plesi, Czech Republic, 26204
        • Pfizer Investigational Site
      • Ostrava-Poruba, Czech Republic, 708 52
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
  • France
      • Angers cedex, France, 49033
        • Pfizer Investigational Site
      • Caen cedex, France, 14033
        • Pfizer Investigational Site
      • Dijon, France
        • Pfizer Investigational Site
      • Limoges, France, 87042
        • Pfizer Investigational Site
      • Nantes Cedex 2, France, 44202
        • Pfizer Investigational Site
      • Paris Cedex 13, France, 75651
        • Pfizer Investigational Site
      • St Herblain Cedex, France, 44805
        • Pfizer Investigational Site
      • Strasbourg, France, 67065 Cedex
        • Pfizer Investigational Site
      • Toulouse cedex 9, France, 31059
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Bielefeld, Germany, 33611
        • Pfizer Investigational Site
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Essen, Germany, 45122
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60590
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76137
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 115 27
        • Pfizer Investigational Site
      • Rio, Patras, Greece, 26500
        • Pfizer Investigational Site
    • Attica
      • Athens, Attica, Greece, 11526
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71 500
        • Pfizer Investigational Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 56 403
        • Pfizer Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1122
        • Pfizer Investigational Site
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Budapest, Hungary, 1529
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4032
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Pfizer Investigational Site
  • Israel
      • Zerifin, Israel, 70300
        • Pfizer Investigational Site
  • Italy
      • Lido di Camaiore (LU), Italy, 55043
        • Pfizer Investigational Site
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Napoli, Italy, 81013
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
  • Mexico
      • Puebla, Mexico, 72530
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 14080
        • Pfizer Investigational Site
  • Netherlands
      • Amstelveen, Netherlands, 1186 AM
        • Pfizer Investigational Site
      • Den Haag, Netherlands, 2545 CH
        • Pfizer Investigational Site
    • GLD
      • Tiel, GLD, Netherlands, 4002 WP
        • Pfizer Investigational Site
    • GR
      • Groningen, GR, Netherlands, 9713 GZ
        • Pfizer Investigational Site
  • Poland
      • Otwock, Poland, 05-400
        • Pfizer Investigational Site
      • Wodzislaw Sl., Poland, 44-300
        • Pfizer Investigational Site
  • Portugal
      • Faro, Portugal, 8000-386
        • Pfizer Investigational Site
      • Porto, Portugal, 4099-001
        • Pfizer Investigational Site
      • Porto, Portugal, 4202
        • Pfizer Investigational Site
      • Vila Nova de Gaia, Portugal, 4400
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7925
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
    • Gauteng
      • Parktown, Gauteng, South Africa
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Santa Cruz de Tenerife, Spain, 38320
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Pfizer Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 118 83
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Pfizer Investigational Site
  • Taiwan
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • Portsmouth, United Kingdom, PO3 6AD
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2SJ
        • Pfizer Investigational Site
      • Surrey GU2 5XX, United Kingdom
        • Pfizer Investigational Site
      • Swansea, United Kingdom, SA2 8QA
        • Pfizer Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Pfizer Investigational Site
  • United States
    • Alaska
      • Little Rock, Alaska, United States, 72205
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Chula Vista, California, United States, 91911
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262-4885
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30306
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
      • Tucker, Georgia, United States, 30084
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61104
        • Pfizer Investigational Site
    • Indiana
      • Jefferson, Indiana, United States, 47130
        • Pfizer Investigational Site
      • New Albany, Indiana, United States, 47150-6809
        • Pfizer Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Pfizer Investigational Site
      • Dubuque, Iowa, United States, 52001
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40241
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40505-4816
        • Pfizer Investigational Site
      • Shelbyville, Kentucky, United States, 40065
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pfizer Investigational Site
      • Gretna, Louisiana, United States, 70056
        • Pfizer Investigational Site
      • Lafayette, Louisiana, United States, 70503
        • Pfizer Investigational Site
      • Marrero, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Maine
      • Biddeford, Maine, United States, 04005
        • Pfizer Investigational Site
      • Brunswick, Maine, United States, 04011
        • Pfizer Investigational Site
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Pfizer Investigational Site
    • Michigan
      • Allegan, Michigan, United States, 49010
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48109-0848
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49048
        • Pfizer Investigational Site
      • St. Joseph, Michigan, United States, 49085
        • Pfizer Investigational Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Pfizer Investigational Site
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68124
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68130
        • Pfizer Investigational Site
      • Papillion, Nebraska, United States, 68046
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Ruidoso, New Mexico, United States, 88345
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
      • Great Neck, New York, United States, 11023
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Pfizer Investigational Site
      • Brevard, North Carolina, United States, 28712
        • Pfizer Investigational Site
      • Lexington, North Carolina, United States, 27292
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Pfizer Investigational Site
      • Dover, Ohio, United States, 44622
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-4491
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227-1191
        • Pfizer Investigational Site
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-3324
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235-7786
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8590
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-9015
        • Pfizer Investigational Site
      • Richardson, Texas, United States, 75080
        • Pfizer Investigational Site
      • Trophy Club, Texas, United States, 76262
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Layton, Utah, United States, 84041
        • Pfizer Investigational Site
      • Murray, Utah, United States, 84107
        • Pfizer Investigational Site
      • Provo, Utah, United States, 84604
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • Pfizer Investigational Site
      • WVC, Utah, United States, 84120
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Pfizer Investigational Site
      • Kennewick, Washington, United States, 99336
        • Pfizer Investigational Site
      • Richland, Washington, United States, 99352
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5666
        • 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:

  • Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
  • No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
  • Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

  • Small cell or carcinoid lung cancer
  • Known Central Nervous System (CNS) metastasis
  • Pre-existing auto-immune or antibody mediated diseases

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: Parallel 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.
Experimental: A
Standard of care chemotherapy plus experiment intervention (PF-3512676)
Drug: PF-3512676 + Paclitaxel + Carboplatin
  • PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
  • Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
  • Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Other Names:
  • Taxol; Paraplatin
Active Comparator: B
Standard of care chemotherapy
Drug: Paclitaxel + Carboplatin
  • Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
  • Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Other Names:
  • Taxol; Paraplatin

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
Time Frame
Overall Survival
Time Frame: 656 Events
656 Events

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
Time Frame
Overall Objective Response
Time Frame: End of Treatment
End of Treatment
Time to Tumor Progression
Time Frame: Time of progressive disease
Time of progressive disease
Progression Free Survival
Time Frame: Time of primary endpoint
Time of primary endpoint
Duration of Response
Time Frame: Time of progressive disease
Time of progressive disease
Patient Reported Outcomes
Time Frame: End of Treatment
End of Treatment
Overall Safety Profile
Time Frame: 28 days post PF-3512676 dosing
28 days post PF-3512676 dosing

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

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.
November 1, 2005

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.
July 1, 2008

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.
July 1, 2008

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).
November 15, 2005

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.
November 15, 2005

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.
November 17, 2005

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.
March 30, 2015

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.
March 10, 2015

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.
March 1, 2015

More Information

Terms related to this study

Keywords

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.
  • A8501001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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