A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

Sponsor
Amgen
Study ID
NCT00356681
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • AMG 706 placebo — DRUG
    Blinded placebo
  • Bevacizumab — DRUG
    Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
  • AMG 706 — DRUG
    AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
  • Paclitaxel — DRUG
    Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.

Study Details

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.

Key Dates

First listed
Jul 26, 2006
Start date
Dec 31, 2006
Status verified
Sep 2015
Primary completion
Feb 28, 2009
Completion
Aug 31, 2012

Study Design

Enrollment
282 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm A Placebo
    Blinded AMG 706 placebo plus paclitaxel
  • Experimental: Arm B Experimental
    Blinded AMG 706 plus paclitaxel
  • Active Comparator: Arm C Comparator
    Open-label bevacizumab plus paclitaxel

Primary Outcome Measure

Objective response rate, measured radiologically and assessed by an independent review committee. [ Time Frame: Last patient enrolled + 16 weeks of treatment ]

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