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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: Docetaxel (Drug); Prednisone (Drug); SU011248 (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

Clinical Details

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)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Prostate Specific Antigen (PSA) Response

Secondary outcome:

Time to PSA Progression

Duration of PSA Response (DPR)

Percentage of Participants With Objective Response Rate (ORR)

Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2

Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3

Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)

Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)

Preliminary Assessment of PSA Modulation by SU011248

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

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 97239-3098, 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, 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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2005
Last updated: August 25, 2011

Page last updated: August 23, 2015

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