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AzTrials

Prostate CancerPhase 2NCT02960022

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

A Phase 2 study testing enzalutamide, abiraterone acetate and prednisone in people with Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 233 sites in 38 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
enzalutamide, abiraterone acetate and prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
233 sitesin 38 countries
Study dates
22 Dec 2016to 31 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
  • Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
  • Subject is able to swallow enzalutamide capsules and comply with study requirements.
  • Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
  • Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
  • Subject agrees not to participate in another interventional study while on treatment.
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  • Canada Specific:
  • Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
  • Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
  • Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
  • Subject is able to swallow enzalutamide capsules and comply with study requirements.
  • Subject is either:
  • Of nonchildbearing potential:
  • postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) > 40 IU/L at Day 1 for women < 55 years of age),
  • documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
  • Or, if of childbearing potential,
  • must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
  • must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
  • must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
  • The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods:
  • A barrier method (e.g., condom by a male partner) is required; AND
  • One of the following is required:
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  • Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
  • Vasectomy or other surgical castration at least 6 months before Day 1.
  • The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
  • Subject agrees not to participate in another interventional study while on treatment.

Who cannot join

  • Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
  • Subject requires treatment with or plans to use either of the following:
  • New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
  • Investigational therapy other than enzalutamide.
  • Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  • Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Show all 14Show fewer
  • Canada Specific:
  • Subject will be excluded from participation if any of the following apply:
  • Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
  • Subject requires treatment with or plans to use any of the following:
  • New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
  • Investigational therapy other than enzalutamide.
  • Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  • Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Trial locations and contacts

233 sites in 38 countries.

233 sites in 38 countries

United States46 sites

  • Site US10052

    Anchorage, Alaska, 99503

  • Site US10001

    Aurora, Colorado, 80045

  • Site US10030

    Chapel Hill, North Carolina, 27599

  • Site US10018

    Charleston, South Carolina, 29414

  • Site US10062

    Charlotte, North Carolina, 28207

  • Site US10002

    Chicago, Illinois, 60637

  • Site US10035

    Cincinnati, Ohio, 45212

  • Site US10010

    Dallas, Texas, 75231

  • Site US10049

    Daytona Beach, Florida, 32114

  • Site US10017

    Denver, Colorado, 80211

  • Site US10024

    Garden City, New York, 11530

  • Site US10031

    Greensboro, North Carolina, 27403

  • Eastern Urological Associates

    Greenville, North Carolina, 27834

  • Site US10004

    Hackensack, New Jersey, 07601

  • Site US10034

    Houston, Texas, 77024

  • Site US10043

    Houston, Texas, 77030

  • Site US10007

    Jeffersonville, Indiana, 47130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Site US10027

    Lancaster, Pennsylvania, 17604

  • Site US10066

    Lenexa, Kansas, 66214-1656

  • Site US10040

    Los Angeles, California, 90024

  • Site US10009

    Los Angeles, California, 90048

  • Site US10021

    Madison, Wisconsin, 53792

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Site US10041

    Nashville, Tennessee, 37232-2765

  • Site US10055

    New York, New York, 10065

  • Site US10059

    New York, New York, 10065

  • Site US10014

    Norfolk, Virginia, 23502

  • Nebraska Medical Hospital

    Omaha, Nebraska, 68114

  • Site US10023

    Omaha, Nebraska, 68130

  • Site US10005

    Pittsburgh, Pennsylvania, 15232

  • Hudson Valley Urology, PC

    Poughkeepsie, New York, 12601

  • Site US10008

    San Bernardino, California, 92404

  • Site US10042

    San Diego, California, 92108

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Site US10038

    Seattle, Washington, 98109

  • Springfield Clinic, LLP

    Springfield, Illinois, 62701

  • Site US10022

    Springfield, Oregon, 97477

  • Site US10032

    St Louis, Missouri, 63110

  • Site US10028

    Stanford, California, 94305

  • Site US10053

    Syracuse, New York, 13210

  • Site US10029

    Towson, Maryland, 21204

  • Site US10011

    Tucson, Arizona, 85741

  • Site US10015

    Virginia Beach, Virginia, 23462

  • Site US10050

    Washington D.C., District of Columbia, 20037

  • Site US10046

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan14 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo

  • Chiba cancer center

    Chiba, 260-8717

  • Harasanshin hospital

    Fukuoka, 812-0033

  • Kyushu University Hospital

    Higashiku, Fukuoka

  • Kagawa University Hospital

    Kida-gun, Kagawa-ken

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koutou-ku, Tokyo

  • Kyoto University hospital

    Kyoto, 606-8507

  • Gunma University Hospital

    Maebashi, Gunma

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8520

  • Osaka Metropolitan University Hospital

    Osaka

  • Toho University Sakura Medical Center

    Sakura-shi, Chiba

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Yamaguchi University Hospital

    Ube, Yamaguchi

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Australia12 sites

  • Site AU61014

    Albury, New South Wales, 2640

  • Site AU61006

    Ashford

  • Site AU61019

    Ballarat, 3350

  • Site AU61007

    East Bentleigh, 3165

  • Site AU61009

    Malvern

  • Site AU61021

    Parkville

  • Site AU61008

    South Brisbane

  • Site AU61016

    St Albans, 3021

  • Site AU61001

    Tweed Heads, New South Wales, 2485

  • Site AU61012

    Wahroonga, New South Wales, 2076

  • Site AU61017

    Wahroonga, New South Wales, 2076

  • Site AU61004

    Westmead, 2145

Other trials in Australia

France12 sites

  • Site FR33021

    Bordeaux, 33076

  • Site FR33008

    La Roche-sur-Yon, 85925

  • Site FR33010

    Lille, 59037

  • Site FR33002

    Lyon, 69003

  • Site FR33020

    Montpellier, 34298

  • Site FR33006

    Nîmes, 30029

  • Site FR33003

    Paris

  • Site FR33017

    Paris

  • Site FR33001

    Saint-Herblain

  • Site FR33019

    Strasbourg, 67000

  • Site FR33022

    Strasbourg, 67098

  • Site FR33004

    Villejuif

Other trials in France

United Kingdom11 sites

  • Site GB44009

    Bebington

  • Site GB44003

    Belfast

  • Site GB44004

    Bristol, BS28HW

  • Site GB44014

    Cambridge

  • Site GB44005

    Cardiff, CF4 4XN

  • Site GB44002

    Glasgow

  • Site GB44006

    London

  • Site GB44007

    Manchester, M20 4BX

  • Site GB44008

    Northwood

  • Site GB44016

    Nottingham, NG5 1PB

  • Site GB44001

    Sutton

Other trials in United Kingdom

South Korea10 sites

  • Site KR82008

    Busan, 49241

  • Site KR82012

    Seongnam-si, 013620

  • Site KR82005

    Seongnam-si

  • Site KR82009

    Seoul, 03080

  • Site KR82007

    Seoul, 06351

  • Site KR82011

    Seoul, 138-736

  • Site KR82001

    Seoul

  • Site KR82002

    Seoul

  • Site KR82003

    Seoul

  • Site KR82004

    Seoul

Other trials in South Korea

Spain9 sites

  • Site ES34007

    Barcelona, 08036

  • Site ES34003

    Barcelona

  • Site ES34011

    Girona, 17007

  • Site ES34012

    Madrid, 28006

  • Site ES34001

    Madrid, 28034

  • Site ES34008

    Madrid

  • Site ES34005

    Pamplona

  • Site ES34014

    Salamanca

  • Site ES34010

    Santiago de Compostela, 15706

Other trials in Spain

Belgium8 sites

  • Site BE32009

    Anderlecht, 1070

  • Site BE32004

    Brussels, B-1090

  • Site BE32011

    Ghent, 9000

  • Site BE32007

    Hasselt

  • Site BE32002

    Kortrijk, West-Vlaanderen, 8500

  • Site BE32008

    Leuven, 3000

  • Site BE32001

    Liège, 4000

  • Site BE32003

    Turnhout, 2300

Other trials in Belgium

Canada8 sites

  • Site CA15019

    Abbotsford British Columbia, V2S 3N5

  • Site CA15001

    Granby, Quebec, J2G 8Z9

  • Site CA15020

    Greenville, L6R 3J7 27834

  • Site CA15003

    Kingston, Ontario, K7L 3J7

  • Site CA15011

    Montreal

  • Site CA15017

    Oakville, L6H 3P1

  • Site CA15022

    Québec, QC / G1S 4L8

  • Site CA15021

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Italy8 sites

  • Site IT39001

    Arezzo

  • Site IT39011

    Candiolo

  • Site IT39004

    Cremona

  • Site IT39008

    Faenza (RA), Emilia-Romagna, 48018

  • Site IT39002

    Forlì

  • Site IT39005

    Roma

  • Site IT39009

    Toscana

  • Site IT39006

    Trento, 38122

Other trials in Italy

Germany7 sites

  • Site DE49010

    Bonn, 53111

  • Site DE49001

    Duisburg, North Rhine-Westphalia, 47179

  • Site DE49003

    Hamburg, 22081

  • Site DE49013

    Hamburg

  • Site DE49006

    Mannheim, DE, 68167

  • Site DE49004

    Nürtingen, Baden-Wurttemberg, 72622

  • Site DE49007

    Waldshut-Tiengen, Baden-Wurttemberg, 79761

Other trials in Germany

Slovakia7 sites

  • Site SK10223

    Bratislava

  • Site SK42109

    Košice, 04001

  • Site SK42106

    Košice, 04191

  • Site SK42105

    Nitra, 949 01

  • Site SK42103

    Prešov, 080 01

  • Site SK42108

    Trenčín, 91101

  • Site SK42107

    Žilina

Other trials in Slovakia

Argentina6 sites

  • Site AR54005

    Buenos Aires, Buenos Aires F.D., C1120AAT

  • Site AR54008

    Buenos Aires

  • Site AR54003

    Cordorba

  • Site AR54007

    Rosario, Santa Fe Province, S2000DSV

  • Site AR54006

    San Miguel de Tucumán, T4000IAK

  • Site AR54002

    San Miguel de Tucumán

Other trials in Argentina

Brazil6 sites

  • Site BR55009

    Bahia, 41253-190

  • Site BR55008

    Campinas

  • Site BR55011

    Jaú

  • Site BR55007

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Site BR55002

    Rio Grande, 90610-000

  • Site BR55010

    Santo André, 09060-650

Other trials in Brazil

Chile6 sites

  • Site CL56004

    IX Region

  • Site CL56007

    Santiago, RM, 7500787

  • Site CL56005

    Santiago, RM, 75009

  • Site CL56002

    Santiago

  • Site CL56006

    Viña del Mar, Valparaiso, 2520598

  • Site CL56001

    Viña del Mar

Other trials in Chile

Poland6 sites

  • Site PL48002

    Gdansk

  • Site PL48001

    Mysłowice

  • Site PL48004

    Pozman

  • Site PL48005

    Słupsk, 76-200

  • Site PL48011

    Warsaw, 04-073

  • Site PL48003

    Wroclaw, 54-144

Other trials in Poland

Russia6 sites

  • Site RU70008

    Ivanovo, 153040

  • Site RU70001

    Moscow, 125284

  • Site RU70005

    Omsk

  • Site RU70009

    Saint Petersburg, 191104

  • Site RU70003

    Saint Petersburg

  • Site RU70006

    Saint Petersburg

Other trials in Russia

Denmark5 sites

  • Site DK45002

    Aalborg, North Denmark, 9000

  • Site DK45003

    Aarhus, 8200

  • Site DK45001

    Copenhagen, 2100

  • Site DK45004

    Herlev, 2730

  • Site DK45006

    Vejle, 7100

Other trials in Denmark

Taiwan5 sites

  • Site TW88607

    Guishan, 33305

  • Site TW88603

    Kaohsiung City, 81362

  • Site TW88601

    Kaohsiung City

  • Site TW88602

    Taichung, 40447

  • Site TW88606

    Taipei, 10002

Other trials in Taiwan

Czechia4 sites

  • Site CZ42004

    Olomouc, 775 20

  • Site CZ42002

    Olomouc, 779 00

  • Site CZ42001

    Prague, 16000

  • Site CZ42003

    Prague

Other trials in Czechia

Israel4 sites

  • Site IL97205

    Jerusalem

  • Site IL97202

    Peth Tikva

  • Site IL97204

    Ramat Gan

  • Site IL97203

    Tzrifin Beer Yakov

Other trials in Israel

Netherlands4 sites

  • Site NL31010

    Amsterdam, 1066 CX

  • Site NL31009

    Den Helder

  • Site NL31004

    Maastricht, 6229

  • Site NL31011

    Rotterdam, 3045 PM

Other trials in Netherlands

Ukraine4 sites

  • Site UA38004

    Dnipro, 49005

  • Site UA38005

    Kharkiv, 61037

  • Site UA38001

    Kyiv, 02125

  • Site UA38003

    Uzhhorod, 88000

Other trials in Ukraine

China3 sites

  • Site CN86003

    Hubei, 430030

  • Site CN86010

    Hunan, 410013

  • Site CN86005

    Nanjing

Other trials in China

New Zealand3 sites

  • Site NZ64002

    Auckland, V2S 3N5

  • Site NZ64005

    Dunedin, 9016

  • Site NZ64001

    Hamilton

Other trials in New Zealand

Romania3 sites

  • Site RO40003

    Bucharest, 50659

  • Site RO40001

    Cluj-Napoca, 400015

  • Site RO40004

    Cluj-Napoca, 400015

Other trials in Romania

Finland2 sites

  • Site FL35802

    Tampere

  • Site FL35805

    Turku, 20521

Other trials in Finland

Serbia2 sites

  • Site RS38102

    Belgrade, 11040

  • Site RS38101

    Belgrade, 11080

Other trials in Serbia

Sweden2 sites

  • Site SE46001

    Gothenburg, 41345

  • Site SE46003

    Umeå, 90185

Other trials in Sweden

Thailand2 sites

  • Site TH66002

    Bangkok, 10330

  • Site TH66001

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

Austria1 site

  • Site AT43001

    Vienna, 1090

Other trials in Austria

Georgia1 site

  • Site GE99501

    Tbilisi, GE- 0186

Other trials in Georgia

Hong Kong1 site

  • Site HK85202

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Site MY60001

    Kuching, 93586

Other trials in Malaysia

Moldova1 site

  • Site MD37301

    Chisinau

Other trials in Moldova

Norway1 site

  • Site NO47001

    Stavanger

Other trials in Norway

South Africa1 site

  • Site ZA27001

    George, 6529

Other trials in South Africa

Turkey (Türkiye)1 site

  • Site TR90002

    Beşevler, Ankara, 06500

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Read the detailed description

Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study) unless the subject is on treatment suspension. The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit.

After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.

Conditions
Prostate Cancer
Being tested
enzalutamide, abiraterone acetate, prednisone, Leuprolide acetate
Keywords
prostate cancer, prednisone, MDV3100, enzalutamide, Xtandi, abiraterone acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • enzalutamideDrug

    Also called MDV3100, Xtandi

    Subjects will receive enzalutamide orally once daily at the same time each day.

  • abiraterone acetateDrug

    Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

  • prednisoneDrug

    Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

  • Leuprolide acetateDrug

    Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Study groups in NCT02960022
Study groupRoleWhat they receive
enzalutamideExperimentalSubjects will receive enzalutamide orally once daily at the same time each day
Receives: Drug: enzalutamide
enzalutamide plus abiraterone acetate and prednisoneExperimentalSubjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
Receives: Drug: enzalutamide; Drug: abiraterone acetate; Drug: prednisone
Enzalutamide plus leuprolide acetateExperimentalSubjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
Receives: Drug: enzalutamide; Drug: Leuprolide acetate

What is being measured

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

  1. Number of participants with adverse events

    Measured: Until End of Study (Up to 96 Months)

Timeline

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

  1. First posted9 Nov 2016 (estimated)
  2. Study start22 Dec 2016
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960022
Sponsor's protocol ID
9785-CL-0123
Other IDs
2016-001694-32, 2023-510298-33-00, jRCT2031220674, 2023, 2016
Status last verified
Oct 2026
First submitted
7 Nov 2016
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enzalutamide, abiraterone acetate and prednisone in people with Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 233 sites in 38 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 27 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in United States, Japan, Australia, France, United Kingdom and 33 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with adverse events (time frame: Until End of Study (Up to 96 Months)). 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 NCT02960022.

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 Oct 2026.

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