Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer (SUNRISE)

April 19, 2017 updated by: Peregrine Pharmaceuticals

SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

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 (Anticipated)

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.
582

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
      • Campbelltown, New South Wales, Australia, 2560
        • Peregrine Pharmaceuticals Investigational Site
      • Camperdown, New South Wales, Australia, 2050
        • Peregrine Pharmaceuticals Investigational Site
      • Tweed Heads, New South Wales, Australia, 2485
        • Peregrine Pharmaceuticals Investigational Site
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Peregrine Pharmaceuticals Investigational Site
      • Redcliffe, Queensland, Australia, 4020
        • Peregrine Pharmaceuticals Investigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Peregrine Pharmaceuticals Investigational Site
      • Toorak Gardens, South Australia, Australia, 5065
        • Peregrine Pharmaceuticals Investigational Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Peregrine Pharmaceuticals Investigational Site
      • Wodonga, Victoria, Australia, 3690
        • Peregrine Pharmaceuticals Investigational Site
  • Belgium
      • Antwerp, Belgium, 2020
        • Peregrine Pharmaceuticals Investigational Site
      • Bruxelles, Belgium, 1000
        • Peregrine Pharmaceuticals Investigational Site
      • Gent, Belgium, 9000
        • Peregrine Pharmaceuticals Investigational Site
      • Herstal, Belgium, 4040
        • Peregrine Pharmaceuticals Investigational Site
      • Liege, Belgium, 4000
        • Peregrine Pharmaceuticals Investigational Site
      • Mechelen, Belgium, 2800
        • Peregrine Pharmaceuticals Investigational Site
      • Namur, Belgium, 5000
        • Peregrine Pharmaceuticals Investigational Site
  • France
      • Rennes, France, 35033
        • Peregrine Pharmaceuticals Investigational Site
      • Saint Priest en Jarez, France, 42271
        • Peregrine Pharmaceuticals Investigational Site
      • Saint-Herblain, France, 44805
        • Peregrine Pharmaceuticals Investigational Site
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13273
        • Peregrine Pharmaceuticals Investigational Site
    • Calvados
      • Caen, Calvados, France, 14076
        • Peregrine Pharmaceuticals Investigational Site
    • Finistere
      • Brest, Finistere, France, 29609
        • Peregrine Pharmaceuticals Investigational Site
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44202
        • Peregrine Pharmaceuticals Investigational Site
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54100
        • Peregrine Pharmaceuticals Investigational Site
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Peregrine Pharmaceuticals Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • Peregrine Pharmaceuticals Investigational Site
      • Berlin, Germany, 13125
        • Peregrine Pharmaceuticals Investigational Site
      • Grosshansdorf, Germany, 22927
        • Peregrine Pharmaceuticals Investigational Site
      • Halle an der Saale, Germany, 06120
        • Peregrine Pharmaceuticals Investigational Site
      • Hamburg, Germany, 21075
        • Peregrine Pharmaceuticals Investigational Site
      • Kassel, Germany, 34125
        • Peregrine Pharmaceuticals Investigational Site
      • Mainz, Germany, 55131
        • Peregrine Pharmaceuticals Investigational Site
      • Munster, Germany, 48149
        • Peregrine Pharmaceuticals Investigational Site
      • Villingen-Schwenningen, Germany, 78052
        • Peregrine Pharmaceuticals Investigational Site
    • Baden-Wuerttemberg
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76137
        • Peregrine Pharmaceuticals Investigational Site
    • Bayern
      • Munchen, Bayern, Germany, 81675
        • Peregrine Pharmaceuticals Investigational Site
    • Hessen
      • Immenhausen, Hessen, Germany, 34376
        • Peregrine Pharmaceuticals Investigational Site
      • Marburg, Hessen, Germany, 35043
        • Peregrine Pharmaceuticals Investigational Site
    • Nordrhein-Westfalen
      • Koln, Nordrhein-Westfalen, Germany, 51109
        • Peregrine Pharmaceuticals Investigational Site
    • Thuringia
      • Erfurt, Thuringia, Germany, 99089
        • Peregrine Pharmaceuticals Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Peregrine Pharmaceuticals Investigational Site
      • Larissa, Greece, 41110
        • Peregrine Pharmaceuticals Investigational Site
      • Thessaloniki, Greece, 56429
        • Peregrine Pharmaceuticals Investigational Site
      • Thessaloniki, Greece, 57010
        • Peregrine Pharmaceuticals Investigational Site
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Peregrine Pharmaceuticals Investigational Site
    • Athens
      • Neo Faliro, Athens, Greece, 18547
        • Peregrine Pharmaceuticals Investigational Site
    • Attiki
      • Athens, Attiki, Greece, 12464
        • Peregrine Pharmaceuticals Investigational Site
    • Crete
      • Chania, Crete, Greece, 73300
        • Peregrine Pharmaceuticals Investigational Site
    • Irakleio
      • Heraklion, Irakleio, Greece, 71110
        • Peregrine Pharmaceuticals Investigational Site
    • Thessaloniki
      • Thermi, Thessaloniki, Greece, 57001
        • Peregrine Pharmaceuticals Investigational Site
  • Hungary
      • Budapest, Hungary, 1121
        • Peregrine Pharmaceuticals Investigational Site
      • Budapest, Hungary, 1125
        • Peregrine Pharmaceuticals Investigational Site
      • Gyor, Hungary, 9023
        • Peregrine Pharmaceuticals Investigational Site
      • Gyula, Hungary, 5703
        • Peregrine Pharmaceuticals Investigational Site
      • Szolnok, Hungary, 5004
        • Peregrine Pharmaceuticals Investigational Site
      • Torokbalint, Hungary, 2045
        • Peregrine Pharmaceuticals Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Peregrine Pharmaceuticals Investigational Site
  • Italy
      • Bergamo, Italy, 24127
        • Peregrine Pharmaceuticals Investigational Site
      • Cremona, Italy, 26100
        • Peregrine Pharmaceuticals Investigational Site
      • Genova, Italy, 16132
        • Peregrine Pharmaceuticals Investigational Site
      • Milan, Italy, 20162
        • Peregrine Pharmaceuticals Investigational Site
      • Turin, Italy, 10126
        • Peregrine Pharmaceuticals Investigational Site
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Peregrine Pharmaceuticals Investigational Site
    • Lucca
      • Lido di Camaiore, Lucca, Italy, 55041
        • Peregrine Pharmaceuticals Investigational Site
    • Messina
      • Taormina, Messina, Italy, 98039
        • Peregrine Pharmaceuticals Investigational Site
    • Monza Brianza
      • Monza, Monza Brianza, Italy, 20900
        • Peregrine Pharmaceuticals Investigational Site
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Peregrine Pharmaceuticals Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Peregrine Pharmaceuticals Investigational Site
      • Cheongju-si, Korea, Republic of, 361711
        • Peregrine Pharmaceuticals Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • Peregrine Pharmaceuticals Investigational Site
      • Seongnam, Korea, Republic of, 463-707
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Peregrine Pharmaceuticals Investigational Site
      • Seoul, Korea, Republic of, 156707
        • Peregrine Pharmaceuticals Investigational Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-380
        • Peregrine Pharmaceuticals Investigational Site
    • Gyonggi-do
      • Suwon, Gyonggi-do, Korea, Republic of, 442-723
        • Peregrine Pharmaceuticals Investigational Site
  • Romania
      • Brasov, Romania, 500091
        • Peregrine Pharmaceuticals Investigational Site
      • Cluj-Napoca, Romania, 400058
        • Peregrine Pharmaceuticals Investigational Site
      • Cluj-Napoca, Romania, 400349
        • Peregrine Pharmaceuticals Investigational Site
      • Ploiesti, Romania, 100337
        • Peregrine Pharmaceuticals Investigational Site
      • Suceava, Romania, 720237
        • Peregrine Pharmaceuticals Investigational Site
      • Turda, Romania, 401103
        • Peregrine Pharmaceuticals Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620036
        • Peregrine Pharmaceuticals Investigational Site
      • Kursk, Russian Federation, 305035
        • Peregrine Pharmaceuticals Investigational Site
      • Nizhny Novgorod, Russian Federation, 603081
        • Peregrine Pharmaceuticals Investigational Site
      • Obninsk, Russian Federation, 249036
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • Peregrine Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • Peregrine Pharmaceuticals Investigational Site
      • Yaroslavl, Russian Federation, 150054
        • Peregrine Pharmaceuticals Investigational Site
  • Spain
      • A Coruna, Spain, 15006
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08003
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08035
        • Peregrine Pharmaceuticals Investigational Site
      • Barcelona, Spain, 08041
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28007
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28040
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28041
        • Peregrine Pharmaceuticals Investigational Site
      • Madrid, Spain, 28050
        • Peregrine Pharmaceuticals Investigational Site
      • Malaga, Spain, 29010
        • Peregrine Pharmaceuticals Investigational Site
      • Valencia, Spain, 46017
        • Peregrine Pharmaceuticals Investigational Site
      • Valencia, Spain, 46026
        • Peregrine Pharmaceuticals Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Peregrine Pharmaceuticals Investigational Site
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Peregrine Pharmaceuticals Investigational Site
      • Manresa, Barcelona, Spain, 08243
        • Peregrine Pharmaceuticals Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Peregrine Pharmaceuticals Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Peregrine Pharmaceuticals Investigational Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Peregrine Pharmaceuticals Investigational Site
      • Putzu, Taiwan, 613
        • Peregrine Pharmaceuticals Investigational Site
      • Taichung, Taiwan, 402
        • Peregrine Pharmaceuticals Investigational Site
      • Taichung, Taiwan, 40705
        • Peregrine Pharmaceuticals Investigational Site
      • Tainan, Taiwan, 704
        • Peregrine Pharmaceuticals Investigational Site
      • Tainan City, Taiwan, 736
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 100
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 10449
        • Peregrine Pharmaceuticals Investigational Site
      • Taipei, Taiwan, 112
        • Peregrine Pharmaceuticals Investigational Site
      • Taoyuan, Taiwan, 333
        • Peregrine Pharmaceuticals Investigational Site
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Peregrine Pharmaceuticals Investigational Site
      • Dnipropetrovsk, Ukraine, 49102
        • Peregrine Pharmaceuticals Investigational Site
      • Khmelnytskyi, Ukraine, 29009
        • Peregrine Pharmaceuticals Investigational Site
      • Kyiv, Ukraine, 03115
        • Peregrine Pharmaceuticals Investigational Site
      • Lutsk, Ukraine, 43018
        • Peregrine Pharmaceuticals Investigational Site
      • Uzhgorod, Ukraine, 88000
        • Peregrine Pharmaceuticals Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Peregrine Pharmaceuticals Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Peregrine Pharmaceuticals Investigational Site
      • Glendale, Arizona, United States, 85306
        • Peregrine Pharmaceuticals Investigational Site
    • California
      • Greenbrae, California, United States, 94904
        • Peregrine Pharmaceuticals Investigational Site
      • Los Angeles, California, United States, 90048
        • Peregrine Pharmaceuticals Investigational Site
      • Oceanside, California, United States, 92056
        • Peregrine Pharmaceuticals Investigational Site
      • Orange, California, United States, 92868
        • Peregrine Pharmaceuticals Investigational Site
      • West Hills, California, United States, 91307
        • Peregrine Pharmaceuticals Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Peregrine Pharmaceuticals Investigational Site
      • Saint Petersburg, Florida, United States, 33705
        • Peregrine Pharmaceuticals Investigational Site
      • Tampa, Florida, United States, 33612
        • Peregrine Pharmaceuticals Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Peregrine Pharmaceuticals Investigational Site
      • Savannah, Georgia, United States, 31404
        • Peregrine Pharmaceuticals Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Peregrine Pharmaceuticals Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Peregrine Pharmaceuticals Investigational Site
    • Louisiana
      • Marrero, Louisiana, United States, 70006
        • Peregrine Pharmaceuticals Investigational Site
      • Shreveport, Louisiana, United States, 71101
        • Peregrine Pharmaceuticals Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Peregrine Pharmaceuticals Investigational Site
      • Frederick, Maryland, United States, 21701
        • Peregrine Pharmaceuticals Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Peregrine Pharmaceuticals Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Peregrine Pharmaceuticals Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Peregrine Pharmaceuticals Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Peregrine Pharmaceuticals Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Peregrine Pharmaceuticals Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Peregrine Pharmaceuticals Investigational Site
      • Middletown, Ohio, United States, 45042
        • Peregrine Pharmaceuticals Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Peregrine Pharmaceuticals Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Peregrine Pharmaceuticals Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Peregrine Pharmaceuticals Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Peregrine Pharmaceuticals Investigational Site
      • Knoxville, Tennessee, United States, 37909
        • Peregrine Pharmaceuticals Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Peregrine Pharmaceuticals Investigational Site
      • Nashville, Tennessee, United States, 37323
        • Peregrine Pharmaceuticals Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Peregrine Pharmaceuticals Investigational Site
      • Dallas, Texas, United States, 75201
        • Peregrine Pharmaceuticals Investigational Site
      • Dallas, Texas, United States, 75390
        • Peregrine Pharmaceuticals Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Peregrine Pharmaceuticals Investigational Site
      • Temple, Texas, United States, 76508
        • Peregrine Pharmaceuticals Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • Peregrine Pharmaceuticals 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

Key Inclusion Criteria:

  • Male or female at least 18 years of age
  • Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
  • Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
  • Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
  • Cavitary tumors or tumors invading or abutting large blood vessels
  • Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
  • Grade 2 or higher peripheral neuropathy

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
  • Masking: DOUBLE

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: bavituximab plus docetaxel
Six 21-day cycles of docetaxel plus weekly bavituximab. Patients who have not experienced disease progression will continue to receive bavituximab weekly until progression.
Drug: Docetaxel
Other Names:
  • Taxotere
Biological: bavituximab
PLACEBO_COMPARATOR: placebo plus docetaxel
Six 21-day cycles of docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive placebo weekly until progression.
Drug: Docetaxel
Other Names:
  • Taxotere
Other: Placebo (for bavituximab)

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: Approximately up to 36 months
Approximately up to 36 months

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
Progression-free survival
Time Frame: Approximately up to 36 months
Approximately up to 36 months
Overall Response Rate
Time Frame: Approximately up to 36 months
Approximately up to 36 months
Safety
Time Frame: Approximately up to 36 months
As measured by adverse event rates and laboratory evaluations
Approximately up to 36 months

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.
Peregrine Pharmaceuticals

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.
December 1, 2013

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.
March 1, 2017

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.
March 1, 2017

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 25, 2013

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 25, 2013

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.
December 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

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.
April 21, 2017

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.
April 19, 2017

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.
April 1, 2017

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.
  • PPHM 1202
  • 2013-003953-13 (EUDRACT_NUMBER)

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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