Prostate Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT00137436

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 23 Locations for this study

See Locations Near You

Pfizer Investigational Site
Harvey Illinois, 60426, United States
Pfizer Investigational Site
Tinley Park Illinois, 60477, United States
Pfizer Investigational Site
Hobart Indiana, 46342, United States
Pfizer Investigational Site
Munster Indiana, 46321, United States
Pfizer Investigational Site
Durham North Carolina, 27710, United States
Pfizer Investigational Site
Portland Oregon, 97239, United States
Pfizer Investigational Site
Portland Oregon, 97239, United States
Pfizer Investigational Site
Myrtle Beach South Carolina, 29572, United States
Pfizer Investigational Site
Clarksville Tennessee, 37043, United States
Pfizer Investigational Site
Franklin Tennessee, 37067, United States
Pfizer Investigational Site
Gallarin Tennessee, 37066, United States
Pfizer Investigational Site
Hermitage Tennessee, 37076, United States
Pfizer Investigational Site
Lebanon Tennessee, 37087, United States
Pfizer Investigational Site
Murfreesboro Tennessee, 37130, United States
Pfizer Investigational Site
Nashville Tennessee, 37203, United States
Pfizer Investigational Site
Nashville Tennessee, 37205, United States
Pfizer Investigational Site
Nashville Tennessee, 37207, United States
Pfizer Investigational Site
Nashville Tennessee, 37211, United States
Pfizer Investigational Site
Smithville Tennessee, 37166, United States
Pfizer Investigational Site
Smyrna Tennessee, 37167, United States
Pfizer Investigational Site
Tullahoma Tennessee, 37388, United States
Pfizer Investigational Site
Dallas Texas, 75246, United States
Pfizer Investigational Site
Houston Texas, 77030, United States
Pfizer Investigational Site
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT00137436

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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