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Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)

NCT00137436•Pfizer

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the prostate
•Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
•Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

•Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
•Prior chemotherapy
•Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
•History of cardiac dysfunction, QT interval corrected for heart rate (QTc) \>450 msec
•Central Nervous System (CNS) involvement

Locations (24)

Pfizer Investigational Site

Harvey, Illinois, United States

Pfizer Investigational Site

Tinley Park, Illinois, United States

Pfizer Investigational Site

Hobart, Indiana, United States

Pfizer Investigational Site

Munster, Indiana, United States

Pfizer Investigational Site

Durham, North Carolina, United States

Pfizer Investigational Site

Portland, Oregon, United States

Pfizer Investigational Site

Portland, Oregon, United States

Pfizer Investigational Site

Myrtle Beach, South Carolina, United States

Pfizer Investigational Site

Clarksville, Tennessee, United States

Pfizer Investigational Site

Franklin, Tennessee, United States

Key Dates

Start Date

October 1, 2005

Primary Completion Date

May 1, 2008

Completion Date

March 1, 2010

Last Updated

August 29, 2011

Enrollment

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

DRUG

Prednisone

DRUG

SU011248

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

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