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

Prostatic Neoplasms Clinical Trial

— SUN 1120  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00676650
• Other study ID #: A6181120
• Status: Terminated
• Phase: Phase 3
• First received: May 8, 2008
• Last updated: February 5, 2013
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 873
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Prednisone
5 mg BID, oral
• sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
• Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen
• Prednisone
5 mg BID, oral

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Port Macquarie	New South Wales
Australia	Pfizer Investigational Site	Wahroong	New South Wales
Australia	Pfizer Investigational Site	Westmead	New South Wales
Australia	Pfizer Investigational Site	Wodonga	Victoria
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Mons
Belgium	Pfizer Investigational Site	Namur
Belgium	Pfizer Investigational Site	Wilrijk
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Caxias do Sul	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	Santo André	SP
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oshawa	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Chongqing
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	WuHan	Hubei
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Olomouc
Czech Republic	Pfizer Investigational Site	Usti nad Labem
Denmark	Pfizer Investigational Site	Herlev
Denmark	Pfizer Investigational Site	Koebenhavn Oe
Denmark	Pfizer Investigational Site	Odense C
Denmark	Pfizer Investigational Site	Vejle
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Tampere
France	Pfizer Investigational Site	Besancon
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Clermont-Ferrand Cedex 1
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Paris Cedex 15
France	Pfizer Investigational Site	Poitiers cedex
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	ROUEN Cedex
France	Pfizer Investigational Site	Saint Gregoire
France	Pfizer Investigational Site	Tours
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Homburg/Saar
Germany	Pfizer Investigational Site	Kempen
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Tuebingen
Germany	Pfizer Investigational Site	Ulm
Israel	Pfizer Investigational Site	Kfar Saba
Israel	Pfizer Investigational Site	Petach Tikva
Israel	Pfizer Investigational Site	Tel Hashomer
Israel	Pfizer Investigational Site	Zerifin
Italy	Pfizer Investigational Site	Lido di Camaiore (LU)
Italy	Pfizer Investigational Site	Meldola	FC
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Potenza
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seongnam	Gyunggido
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Peru	Pfizer Investigational Site	Arequipa
Peru	Pfizer Investigational Site	Bellavista	Callao
Peru	Pfizer Investigational Site	Lima
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Kielce
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Setúbal
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Prešov
Slovakia	Pfizer Investigational Site	Zilina
Spain	Pfizer Investigational Site	A Coruña
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	Gerona
Spain	Pfizer Investigational Site	Guadalajara
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Lund
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Vaxjo
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taoyuan
United Kingdom	Pfizer Investigational Site	Bournemouth	Dorset
United Kingdom	Pfizer Investigational Site	Bristol
United Kingdom	Pfizer Investigational Site	Cardiff
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Guildford
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Northwood,	Middlesex
United Kingdom	Pfizer Investigational Site	Preston	Lancashire
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Swansea
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Arlington Heights	Illinois
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bismarck	North Dakota
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Brighton	Tennessee
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Carmel	Indiana
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Clairton	Pennsylvania
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Corinth	Mississippi
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Danvers	Massachusetts
United States	Pfizer Investigational Site	Decatur	Alabama
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Encinitas	California
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Everett	Washington
United States	Pfizer Investigational Site	Fishers	Indiana
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Greenfield	Indiana
United States	Pfizer Investigational Site	Greensburg	Pennsylvania
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Kernersville	North Carolina
United States	Pfizer Investigational Site	Kingston	Pennsylvania
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lafayette	Colorado
United States	Pfizer Investigational Site	Lafayette	Indiana
United States	Pfizer Investigational Site	Lancaster	Pennsylvania
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lexington	North Carolina
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Mayfield Heights	Ohio
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Mentor	Ohio
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Modesto	California
United States	Pfizer Investigational Site	Monroe	Washington
United States	Pfizer Investigational Site	Mount Airy	North Carolina
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Niles	Illinois
United States	Pfizer Investigational Site	North Wilkesboro	North Carolina
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange Village	Ohio
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Sewell	New Jersey
United States	Pfizer Investigational Site	Southaven	Mississippi
United States	Pfizer Investigational Site	Springfield	Oregon
United States	Pfizer Investigational Site	St. Cloud	Minnesota
United States	Pfizer Investigational Site	Thousand Oaks	California
United States	Pfizer Investigational Site	Thousands Oaks	California
United States	Pfizer Investigational Site	Uniontown	Pennsylvania
United States	Pfizer Investigational Site	Vista	California
United States	Pfizer Investigational Site	Webster	Texas
United States	Pfizer Investigational Site	Westlake	Ohio
United States	Pfizer Investigational Site	Westlake Village	California
United States	Pfizer Investigational Site	Wexford	Pennsylvania
United States	Pfizer Investigational Site	Winfield	Illinois
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winter Park	Florida
United States	Pfizer Investigational Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Peru,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 32 months	No
Secondary	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	Baseline, every 8 weeks up to 123 weeks	No
Secondary	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.	Baseline, every 8 weeks up to 123 weeks	No
Secondary	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	Baseline, every 8 weeks up to 123 weeks	No
Secondary	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.	Day 1 through Day 7 every 28 days (every cycle) up to 29 months	No
Secondary	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.	Baseline, every 4 weeks up to 123 weeks	No
Secondary	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.	Baseline, every 4 weeks up to 123 weeks	No

External Links

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