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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00676650

Purpose

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.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Prednisone Drug: sunitinib Drug: Placebo	Phase III

Study Type:	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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain Severity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Health-related quality of life measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Type, incidence, severity, timing, seriousness, and relatedness of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Progression-Free Survival [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Objective Response Rate and Duration of Response [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	819
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Treatment Arm A - sunitinib + prednisone	Drug: Prednisone 5 mg BID, oral Drug: sunitinib 37.5 mg/day, oral, administered on a continuous daily dosing regimen
B: Placebo Comparator Treatment Arm B - placebo + prednisone	Drug: Placebo 37.5 mg/day, oral, administered on a continuous daily dosing regimen Drug: Prednisone 5 mg BID, oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676650

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 214 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00676650 History of Changes
Other Study ID Numbers:	A6181120
Study First Received:	May 8, 2008
Last Updated:	August 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Docetaxel-refractory mCRPC
Second-line treatment with sunitinib and prednisone

Additional relevant MeSH terms:

Sunitinib
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 01, 2010