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)

Pfizer1 site in 1 country93 target enrollmentOctober 2005

ConditionsProstatic Neoplasms

InterventionsDocetaxel Prednisone SU011248

DrugsDocetaxel Prednisone SU011248

Overview

Phase: Phase 1
Intervention: Docetaxel
Conditions: Prostatic Neoplasms
Sponsor: Pfizer
Enrollment: 93
Locations: 1
Primary Endpoint: Percentage of Participants With Prostate Specific Antigen (PSA) Response
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

March 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

A

SU011248 in combination with docetaxel and prednisone

Intervention: Docetaxel

A

SU011248 in combination with docetaxel and prednisone

Intervention: Prednisone

A

SU011248 in combination with docetaxel and prednisone

Intervention: SU011248

Outcomes

Primary Outcomes

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Time Frame: Baseline, Day 1 of each 21-day cycle

PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.

Secondary Outcomes

Time to PSA Progression(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
Duration of PSA Response (DPR)(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
Percentage of Participants With Objective Response Rate (ORR)(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC(Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
Preliminary Assessment of PSA Modulation by SU011248(Baseline to Day 28)