You are here

Our science / Clinical Trials / Find a Trial / NCT00676650

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

Back to Search Print Save as PDF Bookmark Trial

NCT00676650

Last updated on November 16, 2019
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Decatur, Alabama, 35601 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00676650
Pfizer
Terminated
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Prostatic Neoplasms
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
NCT02616185
Males
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Prednisone
    5 mg BID, oral
    Other Name: Deltasone
  • Drug: sunitinib
    37.5 mg/day, oral, administered on a continuous daily dosing regimen
    Other Name: Sutent, SU011248
  • Drug: Placebo
    37.5 mg/day, oral, administered on a continuous daily dosing regimen
Study Arms  ICMJE
  • Experimental: A
    Treatment Arm A - sunitinib + prednisone
    Interventions:
    • Drug: Prednisone
    • Drug: sunitinib
  • Placebo Comparator: B
    Treatment Arm B - placebo + prednisone
    Interventions:
    • Drug: Placebo
    • Drug: Prednisone
Publications *Michaelson MD, Oudard S, Ou YC, Sengeløv L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullèn 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)		873
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)		819
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion DateDecember 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676650
Other Study ID Numbers  ICMJE A6181120
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now