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Prostatic NeoplasmsPhase 3SUN 1120NCT00676650

Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

A Phase 3 study testing Prednisone and sunitinib in people with Prostatic Neoplasms, run by Pfizer at 205 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Prednisone and sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
873 participants
Where
205 sitesin 22 countries
Study dates
Jul 2008to Dec 2011
Phase
Phase 3
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
  • Progressive disease based on PSA progression, RECIST, or positive bone scan.
  • ECOG 0 or 1.

Who cannot join

  • Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
  • Chemotherapy within 3 weeks.
  • Impending complications from bone metastases.
  • Ongoing urinary obstruction.
  • Cardiac dysfunction, QTc >470 msec.
  • CNS involvement.

Trial locations and contacts

205 sites in 22 countries.

205 sites in 22 countries

United States87 sites

  • Pfizer Investigational Site

    Anaheim, California, 92801

  • Pfizer Investigational Site

    Arlington, Texas, 76014

  • Pfizer Investigational Site

    Arlington Heights, Illinois, 60005

  • Pfizer Investigational Site

    Baltimore, Maryland, 21201

  • Pfizer Investigational Site

    Bismarck, North Dakota, 58501

  • Pfizer Investigational Site

    Boston, Massachusetts, 02114

  • Pfizer Investigational Site

    Brighton, Tennessee, 38011

  • Pfizer Investigational Site

    Carmel, Indiana, 46032

  • Pfizer Investigational Site

    Cary, North Carolina, 27518

  • Pfizer Investigational Site

    Clairton, Pennsylvania, 15025

  • Pfizer Investigational Site

    Cleveland, Ohio, 44106

  • Pfizer Investigational Site

    Corinth, Mississippi, 38834

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Danvers, Massachusetts, 01923

  • Pfizer Investigational Site

    Decatur, Alabama, 35601

  • Pfizer Investigational Site

    Denver, Colorado, 80205

  • Pfizer Investigational Site

    Durham, North Carolina, 27710

  • Pfizer Investigational Site

    Encinitas, California, 92024

  • Pfizer Investigational Site

    Eugene, Oregon, 97401

  • Pfizer Investigational Site

    Everett, Washington, 98201

  • Pfizer Investigational Site

    Fishers, Indiana, 46037

  • Pfizer Investigational Site

    Fort Worth, Texas, 76177

  • Pfizer Investigational Site

    Gainesville, Florida, 32605

  • Pfizer Investigational Site

    Glendale, California, 91206

  • Pfizer Investigational Site

    Greenfield, Indiana, 46140

  • Pfizer Investigational Site

    Greensburg, Pennsylvania, 15601

  • Pfizer Investigational Site

    Henderson, Nevada, 89052

  • Pfizer Investigational Site

    Henderson, Nevada, 89074

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Huntsville, Alabama, 35801

  • Pfizer Investigational Site

    Huntsville, Alabama, 35805

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46219

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46227

  • Pfizer Investigational Site

    Johnstown, Pennsylvania, 15901

  • Pfizer Investigational Site

    Kernersville, North Carolina, 27284

  • Pfizer Investigational Site

    Kingston, Pennsylvania, 18704

  • Pfizer Investigational Site

    La Jolla, California, 92037

  • Pfizer Investigational Site

    Lafayette, Colorado, 80025

  • Pfizer Investigational Site

    Lafayette, Indiana, 47905

  • Pfizer Investigational Site

    Lancaster, Pennsylvania, 17604

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89128

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89148

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89169

  • Pfizer Investigational Site

    Lexington, North Carolina, 27295

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68506

  • Pfizer Investigational Site

    Los Angeles, California, 90033

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Mayfield Heights, Ohio, 44124

  • Pfizer Investigational Site

    Memphis, Tennessee, 38104

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Mentor, Ohio, 44060

  • Pfizer Investigational Site

    Milwaukee, Wisconsin, 53226

  • Pfizer Investigational Site

    Minneapolis, Minnesota, 55455

  • Pfizer Investigational Site

    Modesto, California, 95355

  • Pfizer Investigational Site

    Monroe, Washington, 98272

  • Pfizer Investigational Site

    Mount Airy, North Carolina, 27030

  • Pfizer Investigational Site

    New York, New York, 10032

  • Pfizer Investigational Site

    Niles, Illinois, 60714

  • Pfizer Investigational Site

    North Wilkesboro, North Carolina, 28659

  • Pfizer Investigational Site

    Omaha, Nebraska, 68114

  • Pfizer Investigational Site

    Orange, Ohio, 44122

  • Pfizer Investigational Site

    Orlando, Florida, 32806

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15215

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15237

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27607

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27614

  • Pfizer Investigational Site

    Saint Cloud, Minnesota, 56303-5000

  • Pfizer Investigational Site

    Seattle, Washington, 98101

  • Pfizer Investigational Site

    Sewell, New Jersey, 08080

  • Pfizer Investigational Site

    Southaven, Mississippi, 38671

  • Pfizer Investigational Site

    Springfield, Oregon, 97477

  • Pfizer Investigational Site

    The Bronx, New York, 10461

  • Pfizer Investigational Site

    The Bronx, New York, 10467-2401

  • Pfizer Investigational Site

    Thousand Oaks, California, 91360

  • Pfizer Investigational Site

    Thousands Oaks, California, 91360

  • Pfizer Investigational Site

    Uniontown, Pennsylvania, 15401

  • Pfizer Investigational Site

    Vista, California, 92083

  • Pfizer Investigational Site

    Webster, Texas, 77598

  • Pfizer Investigational Site

    Westlake, Ohio, 44145

  • Pfizer Investigational Site

    Westlake Village, California, 91361

  • Pfizer Investigational Site

    Wexford, Pennsylvania, 15090

  • Pfizer Investigational Site

    Winfield, Illinois, 60190

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27103

  • Pfizer Investigational Site

    Winter Park, Florida, 32789

  • Pfizer Investigational Site

    Zion, Illinois, 60099

Other trials in United States

Spain12 sites

  • Pfizer Investigational Site

    A Coruña, A Coruña, 15006

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08035

  • Pfizer Investigational Site

    Elche, Alicante, 03203

  • Pfizer Investigational Site

    Girona, Gerona, 17007

  • Pfizer Investigational Site

    Guadalajara, Guadalajara, 19002

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, Madrid, 28034

  • Pfizer Investigational Site

    Madrid, Madrid, 28041

  • Pfizer Investigational Site

    Madrid, Madrid, 28050

  • Pfizer Investigational Site

    Pamplona, Navarre, 31008

  • Pfizer Investigational Site

    Seville, Sevilla, 41013

  • Pfizer Investigational Site

    Valencia, Valencia, 46026

Other trials in Spain

France11 sites

  • Pfizer Investigational Site

    Besançon, 25030

  • Pfizer Investigational Site

    Bordeaux, 33076

  • Pfizer Investigational Site

    Clermont-Ferrand, 63011

  • Pfizer Investigational Site

    Lille, 59000

  • Pfizer Investigational Site

    Lyon, 69008

  • Pfizer Investigational Site

    Paris, 75908

  • Pfizer Investigational Site

    Poitiers, 86021

  • Pfizer Investigational Site

    Rennes, 35042

  • Pfizer Investigational Site

    Rouen, 76031

  • Pfizer Investigational Site

    Saint-Grégoire, 35760

  • Pfizer Investigational Site

    Tours, 37044

Other trials in France

United Kingdom11 sites

  • Pfizer Investigational Site

    Bournemouth, Dorset, BH7 7DW

  • Pfizer Investigational Site

    Bristol, BS2 8ED

  • Pfizer Investigational Site

    Cardiff, CF14 2TL

  • Pfizer Investigational Site

    Glasgow, G12 0YN

  • Pfizer Investigational Site

    Glasgow, G52 3NQ

  • Pfizer Investigational Site

    Guildford, GU2 7XX

  • Pfizer Investigational Site

    London, SE1 9RT

  • Pfizer Investigational Site

    Northwood, Middlesex, HA6 2RN

  • Pfizer Investigational Site

    Preston, Lancashire, PR2 9HT

  • Pfizer Investigational Site

    Sheffield, S10 2SJ

  • Pfizer Investigational Site

    Swansea, SA2 8QA

Other trials in United Kingdom

Italy9 sites

  • Pfizer Investigational Site

    Lido Di Camaiore (LU), 55043

  • Pfizer Investigational Site

    Meldola, FC, 47014

  • Pfizer Investigational Site

    Naples, 80131

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Pavia, 27100

  • Pfizer Investigational Site

    Pisa, 56100

  • Pfizer Investigational Site

    Potenza, 85100

  • Pfizer Investigational Site

    Roma, 00135

  • Pfizer Investigational Site

    Roma, 00152

Other trials in Italy

Germany8 sites

  • Pfizer Investigational Site

    Berlin, 10719

  • Pfizer Investigational Site

    Homburg/Saar, 66421

  • Pfizer Investigational Site

    Kempen, 47906

  • Pfizer Investigational Site

    Leipzig, 04109

  • Pfizer Investigational Site

    München, 81675

  • Pfizer Investigational Site

    Münster, 48149

  • Pfizer Investigational Site

    Tübingen, 72076

  • Pfizer Investigational Site

    Ulm, 89081

Other trials in Germany

Brazil6 sites

  • Pfizer Investigational Site

    Belo Horizonte, Minas Gerais, 30150-281

  • Pfizer Investigational Site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Pfizer Investigational Site

    Salvador, Estado de Bahia, 40170-110

  • Pfizer Investigational Site

    Santo André, São Paulo, 09060-650

Other trials in Brazil

Canada6 sites

  • Pfizer Investigational Site

    Barrie, Ontario, L4M 6M2

  • Pfizer Investigational Site

    Kelowna, British Columbia, V1Y 5L3

  • Pfizer Investigational Site

    Montreal, Quebec, H2L 4M1

  • Pfizer Investigational Site

    Montreal, Quebec, H3G 1A4

  • Pfizer Investigational Site

    Oshawa, Ontario, L1G 2B9

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Belgium5 sites

  • Pfizer Investigational Site

    Brussels, 1000

  • Pfizer Investigational Site

    Liège, 4000

  • Pfizer Investigational Site

    Mons, 7000

  • Pfizer Investigational Site

    Namur, 5000

  • Pfizer Investigational Site

    Wilrijk, 2610

Other trials in Belgium

China5 sites

  • Pfizer Investigational Site

    Beijing, 100036

  • Pfizer Investigational Site

    Chongqing, 400038

  • Pfizer Investigational Site

    Shanghai, 200032

  • Pfizer Investigational Site

    Shanghai, 200433

  • Pfizer Investigational Site

    Wuhan, Hubei, 430030

Other trials in China

Slovakia5 sites

  • Pfizer Investigational Site

    Bratislava, 833 10

  • Pfizer Investigational Site

    Bratislava, 85105

  • Pfizer Investigational Site

    Martin, 036 01

  • Pfizer Investigational Site

    Prešov, 080 01

  • Pfizer Investigational Site

    Žilina, 012 07

Other trials in Slovakia

South Korea5 sites

  • Pfizer Investigational Site

    Goyang-si, Gyeonggi-do, 410-769

  • Pfizer Investigational Site

    Seongnam, Gyunggido, 463-802

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 135-710

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Australia4 sites

  • Pfizer Investigational Site

    Port Macquarie, New South Wales, 2444

  • Pfizer Investigational Site

    Wahroong, New South Wales, 2076

  • Pfizer Investigational Site

    Westmead, New South Wales, 2145

  • Pfizer Investigational Site

    Wodonga, Victoria, 3690

Other trials in Australia

Denmark4 sites

  • Pfizer Investigational Site

    Herlev, 2730

  • Pfizer Investigational Site

    Koebenhavn Oe, 2100

  • Pfizer Investigational Site

    Odense C, 5000

  • Pfizer Investigational Site

    Vejle, 7100

Other trials in Denmark

Israel4 sites

  • Pfizer Investigational Site

    Kfar Saba

  • Pfizer Investigational Site

    Petah Tikva, 49100

  • Pfizer Investigational Site

    Tel HaShomer, 52621

  • Pfizer Investigational Site

    Tsrifin, 70300

Other trials in Israel

Poland4 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Kielce, 25-734

  • Pfizer Investigational Site

    Warsaw, 02-507

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

Sweden4 sites

  • Pfizer Investigational Site

    Lund, 221 85

  • Pfizer Investigational Site

    Malmö, 205 02

  • Pfizer Investigational Site

    Stockholm, 171 76

  • Pfizer Investigational Site

    Vaxjo, 351 85

Other trials in Sweden

Taiwan4 sites

  • Pfizer Investigational Site

    Taichung, 407

  • Pfizer Investigational Site

    Taipei, 100

  • Pfizer Investigational Site

    Taipei, 112

  • Pfizer Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Czechia3 sites

  • Pfizer Investigational Site

    Brno, 625 00

  • Pfizer Investigational Site

    Olomouc, 775 20

  • Pfizer Investigational Site

    Ústí nad Labem, 40113

Other trials in Czechia

Peru3 sites

  • Pfizer Investigational Site

    Arequipa, Arequipa

  • Pfizer Investigational Site

    Bellavista, Provincia Constitucional del Callao, Callao 02

  • Pfizer Investigational Site

    Lima, Lima Province, Lima 27

Other trials in Peru

Portugal3 sites

  • Pfizer Investigational Site

    Porto, 4200-072

  • Pfizer Investigational Site

    Porto, 4200-319

  • Pfizer Investigational Site

    Setúbal, 2910-446

Other trials in Portugal

Finland2 sites

  • Pfizer Investigational Site

    Helsinki, 00290

  • Pfizer Investigational Site

    Tampere, 33520

Other trials in Finland

About this study

Official title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Being tested
Prednisone, sunitinib, Placebo
Keywords
Docetaxel-refractory mCRPC, Second-line treatment with sunitinib and prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • PrednisoneDrug

    Also called Deltasone

    5 mg BID, oral

  • sunitinibDrug

    Also called Sutent, SU011248

    37.5 mg/day, oral, administered on a continuous daily dosing regimen

  • PlaceboDrug

    37.5 mg/day, oral, administered on a continuous daily dosing regimen

  • PrednisoneDrug

    Also called Deltasone

    5 mg BID, oral

Study groups in NCT00676650
Study groupRoleWhat they receive
AExperimentalTreatment Arm A - sunitinib + prednisone
Receives: Drug: Prednisone; Drug: sunitinib
BPlacebo comparatorTreatment Arm B - placebo + prednisone
Receives: Drug: Placebo; Drug: Prednisone

What is being measured

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

  1. Overall Survival (OS)

    OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.

    Measured: Baseline up to 32 months

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02

    Measured: Baseline, every 8 weeks up to 123 weeks

  2. Percent of Participants With Objective Response (OR)

    OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.

    Measured: Baseline, every 8 weeks up to 123 weeks

  3. Duration of Response (DR)

    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response

    Measured: Baseline, every 8 weeks up to 123 weeks

  4. Change From Baseline in Pain Severity

    Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.

    Measured: Day 1 through Day 7 every 28 days (every cycle) up to 29 months

  5. Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.

    Measured: Baseline, every 4 weeks up to 123 weeks

  6. Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

    Measured: Baseline, every 4 weeks up to 123 weeks

Timeline

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

  1. First posted13 May 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Why it stopped: Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676650
Sponsor's protocol ID
A6181120
Acronym
SUN 1120
Status last verified
Feb 2013
First submitted
8 May 2008
Last updated
8 Mar 2013
Data monitoring committee
Yes

Publications

  • Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

    PubMed 24323035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prednisone and sunitinib in people with Prostatic Neoplasms, run by Pfizer at 205 sites in 22 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Spain, France, United Kingdom, Italy and 17 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Mar 2013). 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?

Overall Survival (OS) (time frame: Baseline up to 32 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 NCT00676650, which also lists 1 linked publication.

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 8 Mar 2013.

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