Trials / Terminated
TerminatedNCT00356681
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 282 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 706 placebo | Blinded placebo |
| DRUG | Bevacizumab | Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody. |
| DRUG | AMG 706 | 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. |
| DRUG | Paclitaxel | Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules. |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2009-02-01
- Completion
- 2012-08-01
- First posted
- 2006-07-26
- Last updated
- 2015-10-15
Source: ClinicalTrials.gov record NCT00356681. Inclusion in this directory is not an endorsement.