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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Outcome Description:

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

Outcome Time Frame:

Baseline, Day 1 of each 21-day cycle

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181043

NCT ID:

NCT00137436

Start Date:

October 2005

Completion Date:

March 2010

Related Keywords:

  • Prostatic Neoplasms
  • First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Bristol, Tennessee  37620