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Advanced, Androgen Receptor Positive Triple Negative Breast CancerPhase 2NCT01889238

Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

A Phase 2 study testing Enzalutamide in people with Advanced, Androgen Receptor Positive Triple Negative Breast Cancer, run by Pfizer at 132 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
132 sitesin 7 countries
Study dates
12 Jun 2013to 10 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women at least 18 years of age;
  • Advanced AR+ TNBC;
  • Availability of a representative tumor specimen:
  • Either measurable disease or bone only nonmeasurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • Any severe concurrent disease, infection, or comorbid condition;
  • Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
  • Current or previously treated brain metastasis or active leptomeningeal disease;
  • Current hormone replacement therapy;
  • Local palliative radiation therapy within 7 days before day 1;
  • History of another invasive cancer within 5 years of day 1;
Show all 17Show fewer
  • Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
  • Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Active gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks before day 1;
  • Treatment with any commercially available anticancer agent within 14 days before day 1;
  • Treatment with any investigational agent within 2 weeks before day 1;
  • Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
  • Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.

Trial locations and contacts

132 sites in 7 countries.

132 sites in 7 countries

United States95 sites

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Florida Cancer Specialists

    Cape Coral, Florida, 33914

  • Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories

    Chicago, Illinois, 60611

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy

    Chicago, Illinois, 60637

  • The University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45211

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • The West Clinic, PC

    Corinth, Mississippi, 38834

  • Oncology Hematology Care, Inc.

    Crestview Hills, Kentucky, 41017

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Oncology Hematology Care, Inc.

    Fairfield, Ohio, 45014

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialist South Division

    Fort Myers, Florida, 33908

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Wesley Long Community Hospital

    Greensboro, North Carolina, 27403

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Florida Cancer Specialists

    Hudson, Florida, 34667

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Investigational Drug Services

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Clinic

    Indianapolis, Indiana, 46290

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Rocky Mountain Cancer Center Sky Ridge

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Virginia Cancer Institute

    Mechanicsville, Virginia, 23116-1844

  • The West Clinic, PC

    Memphis, Tennessee, 38104

  • The West Clinic, PC

    Memphis, Tennessee, 38120

  • Virginia Cancer Institute

    Midlothian, Virginia, 23114

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07962

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt Health Pharmacy One Hundred Oaks

    Nashville, Tennessee, 37204

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service

    New York, New York, 10065

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Virginia Cancer Institute

    Richmond, Virginia, 23235-4730

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Greenville Health System

    Seneca, South Carolina, 29672

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • The West Clinic, PC

    Southaven, Mississippi, 38671

  • Greenville Health System

    Spartanburg, South Carolina, 29307

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University Infusion Center Pharmacy

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center-West County

    St Louis, Missouri, 63141

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    Venice, Florida, 34285

  • Florida Cancer Specialists

    Venice, Florida, 34292

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

Other trials in United States

United Kingdom11 sites

  • Clinical Investigation and Research Unit

    Brighton, England, BN2 5BE

  • Pharmacy Department

    Brighton, England, BN2 5BE

  • Radiation Safety Service, Medical Physics Department

    Brighton, England, BN2 5BE

  • Histopathology Department

    Nottingham, England, NG5 1PB

  • Nottingham University Hospital

    Nottingham, England, NG5 1PB

  • Pharmacy Department

    Nottingham, England, NG5 1PB

  • Radiology Department

    Nottingham, England, NG5 1PB

  • Radiology Department

    Nottingham, England, NG7 2UH

  • Department of Radiology

    Truro, England, TR1 3LJ

  • Pharmacy Department

    Truro, England, TR1 3LJ

  • Royal Cornwall Hospitals NHS trust

    Truro, Cornwall, England, TR1 3LJ

Other trials in United Kingdom

Ireland10 sites

  • Department of Radiology

    Dooradoyle, Limerick

  • 3rd Floor,Oncology Link office

    Dublin, 4

  • Department of Radiology

    Dublin, 4

  • Institute for Cancer Research

    Dublin, 7

  • Mater Private Hospital

    Dublin, 7

  • Pharmacy Department

    Dublin, 7

  • Radiology Department

    Dublin, 7

  • Pharmacy Department

    Dublin

  • Cancer Clinical Trials Unit, Mid-Western Cancer center

    Limerick

  • Pharmacy Department

    Limerick

Other trials in Ireland

Spain7 sites

  • Grupo Hospitalario Quiron - Hospital Quiron Barcelona

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 Octubre

    Madrid, 28041

  • Centro Intergral Oncologico Clara Campal

    Madrid, 28050

  • Hospital de Madrid Norte-Sanchinarro.

    Madrid, 28050

Other trials in Spain

Italy4 sites

  • Dipartimento di Oncologia Medica, IRCCS Ospedale San Raffaele

    Milan, 20132

  • Farmacia (magazzino ricevimento merc), IRCCS Ospedale San Raffaele

    Milan, 20132

  • U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi

    Prato, 59100

  • U.O. Oncologia Medica, Nuovo Ospedale di Prato

    Prato, 59100

Other trials in Italy

Canada3 sites

  • McGill University Health Centre-Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Belgium2 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZA

    Edegem, Antwerpen, 2650

Other trials in Belgium

About this study

Official title: A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER

The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

Being tested
Enzalutamide
Keywords
breast cancer, triple negative, androgen receptor positive
Medical subject headings
Breast Neoplasms

What participants receive

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

  • EnzalutamideDrug

    Also called Xtandi®, MDV3100

    160 mg administered as four soft gelatin capsules orally once daily

Study groups in NCT01889238
Study groupRoleWhat they receive
EnzalutamideExperimental160 mg administered as four 40 mg soft gelatin capsules orally once daily
Receives: Drug: Enzalutamide

What is being measured

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

  1. Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population

    Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >=16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

    Measured: Week 16

  2. Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population

    Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

    Measured: Week 16

Secondary outcomes (9)

  1. Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population

    Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

    Measured: Week 24

  2. Percentage of Participants With Clinical Benefit at Week 24: ITT Population

    Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.

    Measured: Week 24

  3. Percentage of Participants With Best Objective Response: Evaluable Population

    Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.

    Measured: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)

  4. Percentage of Participants With Best Objective Response: ITT Population

    Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.

    Measured: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)

  5. Progression-Free Survival (PFS): Evaluable Population

    PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.

    Measured: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)

  6. Progression-Free Survival: ITT Population

    PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.

    Measured: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)

  7. Time to Response: Evaluable Population

    The time to response is defined as the time from the date of first dose of study drug to initial CR or PR. Participants without response of CR or PR before the data cutoff date were censored at the last tumor assessment date before the data cutoff. Kaplan-Meier method was used to summarize time to response.

    Measured: From first dose of study drug until first documentation of CR or PR or data censoring date, whichever occurred first (up to 87 Weeks)

  8. Duration of Response: Evaluable Population

    Duration of objective response is defined as the time from initial CR or PR to documented disease progression or death due to any cause, whichever occurs first. Participants without disease progression or death due to any cause before the data cutoff date were censored at the last tumor assessment date before the data cutoff.

    Measured: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (up to 87 Weeks)

  9. Number of Participants With Postbaseline Laboratory Toxicities Grade 3 or 4

    Laboratory parameters included hematology parameters [low lymphocytes (10^6/L), neutrophils (10^6/L) and Leukocytes (10^9/L)] and chemistry parameters [high phosphate (mmol/L), bilirubin, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with postbaseline laboratory toxicity Grade 3 or 4 as per NCI-CTCAE (version 4.0) (Grade 3= Severe, Grade 4= Life-threatening) were reported.

    Measured: From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years)

Timeline

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

  1. First posted28 Jun 2013 (estimated)
  2. Study start12 Jun 2013
  3. Primary completion1 Mar 2015
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889238
Sponsor's protocol ID
MDV3100-11
Other IDs
2013-000698-57, C3431007
Status last verified
Nov 2024
First submitted
26 Jun 2013
Last updated
13 Dec 2024
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Kumar V, Yu J, Phan V, Tudor IC, Peterson A, Uppal H. Androgen Receptor Immunohistochemistry as a Companion Diagnostic Approach to Predict Clinical Response to Enzalutamide in Triple-Negative Breast Cancer. JCO Precis Oncol. 2017 Nov;1:1-19. doi: 10.1200/PO.17.00075.

    PubMed 35172518

  • Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26.

    PubMed 29373071

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide in people with Advanced, Androgen Receptor Positive Triple Negative Breast Cancer, run by Pfizer at 132 sites in 7 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 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, United Kingdom, Ireland, Spain, Italy and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2018). 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?

Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889238, which also lists 2 linked publications.

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 13 Dec 2024.

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