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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00356681
Recruitment Status : Terminated (Sponsor decision to close study)
First Posted : July 26, 2006
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Tumors Breast Cancer Locally Recurrent and Metastatic Breast Cancer Drug: AMG 706 placebo Drug: Bevacizumab Drug: AMG 706 Drug: Paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Primary Completion Date : February 2009
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Arm A Placebo
Blinded AMG 706 placebo plus paclitaxel
Drug: AMG 706 placebo
Blinded placebo
Drug: Paclitaxel
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
Experimental: Arm B Experimental
Blinded AMG 706 plus paclitaxel
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.
Other Name: motesanib diphosphate
Drug: Paclitaxel
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
Active Comparator: Arm C Comparator
Open-label bevacizumab plus paclitaxel
Drug: Bevacizumab
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.



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

Secondary Outcome Measures :
  1. 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. [ Time Frame: >24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
  • Measurable disease by RECIST guidelines.
  • Tumor (primary or metastatic) must be HER2 negative.
  • Adequate organ and hematologic function. Exclusion:
  • Taxane treatment within 12 months prior to registration.
  • Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
  • Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
  • Current or prior history of central nervous system metastases.
  • Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
  • History of arterial or venous thrombosis within 1 year prior to registration.
  • History of bleeding diathesis or bleeding within 14 days of registration.
  • Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).
  • Clinically significant cardiac disease within 12 months of registration.
  • Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
  • Prior treatment with VEGFr targeted therapies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356681


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00356681     History of Changes
Other Study ID Numbers: 20050225
CIRG/TORI 010
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: September 2015

Keywords provided by Amgen:
AMG 706
Paclitaxel
Metastatic Breast Cancer
Antiangiogenic
Bevacizumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Niacinamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Vitamin B Complex
Vitamins
Micronutrients