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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Decatur, Alabama, 35601 United States
Contact
1-800-718-1021
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

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Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostatic Neoplasms
  • 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
  • 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
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.
 
Terminated
873
December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00676650
A6181120
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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