Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)

February 5, 2013 updated by: Pfizer

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

873

Phase

  • 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

    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Pfizer Investigational Site
      • Wahroong, New South Wales, Australia, 2076
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Victoria
      • Wodonga, Victoria, Australia, 3690
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
      • Mons, Belgium, 7000
        • Pfizer Investigational Site
      • Namur, Belgium, 5000
        • Pfizer Investigational Site
      • Wilrijk, Belgium, 2610
        • Pfizer Investigational Site
    • BA
      • Salvador, BA, Brazil, 40170-110
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brazil, 30150-281
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22260-020
        • Pfizer Investigational Site
    • RS
      • Caxias do Sul, RS, Brazil, 95070-560
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90050-170
        • Pfizer Investigational Site
    • SP
      • Santo André, SP, Brazil, 09060-650
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Pfizer Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • Beijing, China, 100036
        • Pfizer Investigational Site
      • Chongqing, China, 400038
        • Pfizer Investigational Site
      • Shanghai, China, 200433
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
    • Hubei
      • WuHan, Hubei, China, 430030
        • Pfizer Investigational Site
      • Brno, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 40113
        • Pfizer Investigational Site
      • Herlev, Denmark, 2730
        • Pfizer Investigational Site
      • Koebenhavn Oe, Denmark, 2100
        • Pfizer Investigational Site
      • Odense C, Denmark, 5000
        • Pfizer Investigational Site
      • Vejle, Denmark, 7100
        • Pfizer Investigational Site
      • Helsinki, Finland, 00290
        • Pfizer Investigational Site
      • Tampere, Finland, 33520
        • Pfizer Investigational Site
      • Besancon, France, 25030
        • Pfizer Investigational Site
      • Bordeaux Cedex, France, 33076
        • Pfizer Investigational Site
      • Clermont-Ferrand Cedex 1, France, 63011
        • Pfizer Investigational Site
      • Lille, France, 59000
        • Pfizer Investigational Site
      • Lyon, France, 69008
        • Pfizer Investigational Site
      • Paris Cedex 15, France, 75908
        • Pfizer Investigational Site
      • Poitiers cedex, France, 86021
        • Pfizer Investigational Site
      • ROUEN Cedex, France, 76031
        • Pfizer Investigational Site
      • Rennes, France, 35042
        • Pfizer Investigational Site
      • Saint Gregoire, France, 35760
        • Pfizer Investigational Site
      • Tours, France, 37044
        • Pfizer Investigational Site
      • Berlin, Germany, 10719
        • Pfizer Investigational Site
      • Homburg/Saar, Germany, 66421
        • Pfizer Investigational Site
      • Kempen, Germany, 47906
        • Pfizer Investigational Site
      • Leipzig, Germany, 04109
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
      • Ulm, Germany, 89081
        • Pfizer Investigational Site
      • Kfar Saba, Israel
        • Pfizer Investigational Site
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52621
        • Pfizer Investigational Site
      • Zerifin, Israel, 70300
        • Pfizer Investigational Site
      • Lido di Camaiore (LU), Italy, 55043
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Pisa, Italy, 56100
        • Pfizer Investigational Site
      • Potenza, Italy, 85100
        • Pfizer Investigational Site
      • Roma, Italy, 00152
        • Pfizer Investigational Site
      • Roma, Italy, 00135
        • Pfizer Investigational Site
    • FC
      • Meldola, FC, Italy, 47014
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Pfizer Investigational Site
    • Gyunggido
      • Seongnam, Gyunggido, Korea, Republic of, 463-802
        • Pfizer Investigational Site
      • Arequipa, Peru
        • Pfizer Investigational Site
      • Lima, Peru, Lima 27
        • Pfizer Investigational Site
    • Callao
      • Bellavista, Callao, Peru, Callao 02
        • Pfizer Investigational Site
      • Gdansk, Poland, 80-952
        • Pfizer Investigational Site
      • Kielce, Poland, 25-734
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-507
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-072
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-319
        • Pfizer Investigational Site
      • Setúbal, Portugal, 2910-446
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 10
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 85105
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 01
        • Pfizer Investigational Site
      • Prešov, Slovakia, 080 01
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site
      • A Coruña, Spain, 15006
        • Pfizer Investigational Site
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Guadalajara, Spain, 19002
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28050
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Valencia, Spain, 46026
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Pfizer Investigational Site
      • Lund, Sweden, 221 85
        • Pfizer Investigational Site
      • Malmo, Sweden, 205 02
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
      • Vaxjo, Sweden, 351 85
        • Pfizer Investigational Site
      • Taichung, Taiwan, 407
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taoyuan, Taiwan, 333
        • Pfizer Investigational Site
      • Bristol, United Kingdom, BS2 8ED
        • Pfizer Investigational Site
      • Cardiff, United Kingdom, CF14 2TL
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G12 0YN
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G52 3NQ
        • Pfizer Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2SJ
        • Pfizer Investigational Site
      • Swansea, United Kingdom, SA2 8QA
        • Pfizer Investigational Site
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Pfizer Investigational Site
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Pfizer Investigational Site
    • Middlesex
      • Northwood,, Middlesex, United Kingdom, HA6 2RN
        • Pfizer Investigational Site
    • Alabama
      • Decatur, Alabama, United States, 35601
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35805
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Encinitas, California, United States, 92024
        • Pfizer Investigational Site
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Modesto, California, United States, 95355
        • Pfizer Investigational Site
      • Thousand Oaks, California, United States, 91360
        • Pfizer Investigational Site
      • Thousands Oaks, California, United States, 91360
        • Pfizer Investigational Site
      • Vista, California, United States, 92083
        • Pfizer Investigational Site
      • Westlake Village, California, United States, 91361
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80205
        • Pfizer Investigational Site
      • Lafayette, Colorado, United States, 80025
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32605
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Winter Park, Florida, United States, 32789
        • Pfizer Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Pfizer Investigational Site
      • Niles, Illinois, United States, 60714
        • Pfizer Investigational Site
      • Winfield, Illinois, United States, 60190
        • Pfizer Investigational Site
      • Zion, Illinois, United States, 60099
        • Pfizer Investigational Site
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Pfizer Investigational Site
      • Fishers, Indiana, United States, 46037
        • Pfizer Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46227
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46219
        • Pfizer Investigational Site
      • Lafayette, Indiana, United States, 47905
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Danvers, Massachusetts, United States, 01923
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
      • St. Cloud, Minnesota, United States, 56303-5000
        • Pfizer Investigational Site
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
      • Southaven, Mississippi, United States, 38671
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, United States, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89169
        • Pfizer Investigational Site
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10467-2401
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
      • Kernersville, North Carolina, United States, 27284
        • Pfizer Investigational Site
      • Lexington, North Carolina, United States, 27295
        • Pfizer Investigational Site
      • Mount Airy, North Carolina, United States, 27030
        • Pfizer Investigational Site
      • North Wilkesboro, North Carolina, United States, 28659
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27614
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Pfizer Investigational Site
      • Mentor, Ohio, United States, 44060
        • Pfizer Investigational Site
      • Orange Village, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Westlake, Ohio, United States, 44145
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Springfield, Oregon, United States, 97477
        • Pfizer Investigational Site
    • Pennsylvania
      • Clairton, Pennsylvania, United States, 15025
        • Pfizer Investigational Site
      • Greensburg, Pennsylvania, United States, 15601
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15901
        • Pfizer Investigational Site
      • Kingston, Pennsylvania, United States, 18704
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15215
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15237
        • Pfizer Investigational Site
      • Uniontown, Pennsylvania, United States, 15401
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, United States, 15090
        • Pfizer Investigational Site
    • Tennessee
      • Brighton, Tennessee, United States, 38011
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76177
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Webster, Texas, United States, 77598
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Pfizer Investigational Site
      • Monroe, Washington, United States, 98272
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98101
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Treatment Arm A - sunitinib + prednisone
5 mg BID, oral
Other Names:
  • Deltasone
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Other Names:
  • Sutent, SU011248
Placebo Comparator: B
Treatment Arm B - placebo + prednisone
5 mg BID, oral
Other Names:
  • Deltasone
37.5 mg/day, oral, administered on a continuous daily dosing regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to 32 months
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.
Baseline up to 32 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline, every 8 weeks up to 123 weeks
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
Baseline, every 8 weeks up to 123 weeks
Percent of Participants With Objective Response (OR)
Time Frame: Baseline, every 8 weeks up to 123 weeks
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.
Baseline, every 8 weeks up to 123 weeks
Duration of Response (DR)
Time Frame: Baseline, every 8 weeks up to 123 weeks
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
Baseline, every 8 weeks up to 123 weeks
Change From Baseline in Pain Severity
Time Frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months
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.
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame: Baseline, every 4 weeks up to 123 weeks
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.
Baseline, every 4 weeks up to 123 weeks
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Time Frame: Baseline, every 4 weeks up to 123 weeks
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.
Baseline, every 4 weeks up to 123 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

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

July 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 8, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

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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