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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival (OS)

Outcome Description:

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.

Outcome Time Frame:

Baseline up to 32 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181120

NCT ID:

NCT00676650

Start Date:

July 2008

Completion Date:

December 2011

Related Keywords:

  • Prostatic Neoplasms
  • Docetaxel-refractory mCRPC
  • Second-line treatment with sunitinib and prednisone
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteBismarck, North Dakota  58503