Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00519285
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    25 mg/ml solution 6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle
  • Placebo (for aflibercept) — DRUG
    Sterile aqueous buffered solution identical to aflibercept 1-hour IV on Day 1 of each 3-Week cycle
  • Docetaxel — DRUG
    Marketed formulation 75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)
  • Prednisone or Prednisolone — DRUG
    Marketed formulation 5 mg twice daily PO from day 1 continuously

Study Details

Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: * To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); * To assess the overall safety in both treatment arms; * To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; * to determine immunogenicity of IV aflibercept.

Key Dates

Start date
Aug 31, 2007
Status verified
Jun 2016
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
1,224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone
  • Experimental: Aflibercept
    Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Primary Outcome Measure

Overall Survival Time [ Time Frame: From randomization up to the cut-off date (median follow-up of 35.4 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Sanofi-Aventis Administrative Office· Bridgewater, NJ

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