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)...
Date First Received: August 26, 2005
Last Updated: July 16, 2008
Verified by: Pfizer, July 2008
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: October 2005
Overall Status: Recruiting
Estimated Enrollment: 92
Brief Summary
Official Title: “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)”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Phase 1 - To evaluate the pharmacokinetics of SU011248 and docetaxel when co-administered with prednisone 18 months Yes
- Phase 2 - To assess the anti-tumor activity of SU011248 in combination with docetaxel and prednisone (PSA response rate) 12 months No
- Phase 1 - To determine the optimal combination dose and overall safety and tolerability of SU011248 administered in combination with docetaxel and prednisone 18 months Yes
Secondary:
- Phase 2 - To assess the duration of tumor control (time to PSA progression and duration of PSA response) 12 months No
- Phase 2 - Exploratory analyses of biomarkers 12 months No
- Phase 2 - Patient reported outcomes 12 months No
- Phase 2 - Objective tumor response rate 12 months No
Criteria for Participation in this Clinical Trial
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
- ECOG performance status 0 or 1
Exclusion Criteria:
- Prior thalidomide, anti-VEGF therapy, VEGF receptor inhibitor, 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, QTC >450 msec
- CNS involvement
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
Pfizer Investigational Site
Harvey Illinois 60426 United States
Pfizer Investigational Site
Tinley Park Illinois 60477 United States
Pfizer Investigational Site
Munster Indiana 46321 United States
Pfizer Investigational Site
Durham North Carolina 27705 United States
Pfizer Investigational Site
Portland Oregon 97239 United States
Pfizer Investigational Site
Portland Oregon 97239-3098 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
Smyrna Tennessee 37167 United States
Pfizer Investigational Site
Tullahoma Tennessee 37388 United States
Pfizer Investigational Site
Houston Texas 77030 United States
Pfizer Investigational Site
Dallas Texas 75246 United States
Pfizer Investigational Site
Madison Wisconsin 53792 United States
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Overall Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00137436
Study ID Number: A6181043
ClinicalTrials.gov Identifier: NCT00137436
Health Authority: United States: Food and Drug Administration
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
