Sponsor decision to close study
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
Sponsor study identifier
Secondary identifiers
interventional
282
0 countries
N/A
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
August 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2006
Actual (reported)July 26, 2006
Actual (reported)December 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 2009
Actual (reported)August 2012
Actual (reported)Objective response rate, measured radiologically and assessed by an independent review committee.
Last patient enrolled + 16 weeks of treatment
Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.
>24 weeks
Blinded AMG 706 placebo plus paclitaxel
Blinded AMG 706 plus paclitaxel
Open-label bevacizumab plus paclitaxel
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21.
MD
Amgen
282 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2006
First Posted
July 26, 2006
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
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 is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
Contact the study team to confirm eligibility.
Primary Completion
February 2009
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
October 15, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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