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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00356681 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Breast Tumors Breast Cancer Locally Recurrent and Metastatic Breast Cancer |
Drug: AMG 706 placebo Drug: Bevacizumab Drug: AMG 706 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 282 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
Blinded AMG 706 placebo
|
Drug: AMG 706 placebo
AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
|
|
B: Active Comparator
Blinded AMG 706
|
Drug: AMG 706
AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity
|
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C: Experimental
Open-label bevacizumab
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Drug: Bevacizumab
Bevacizumab 10 mg/kg IV every 14 days until disease progression, consent withdrawal or unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20050225, CIRG/TORI 010 |
| Study First Received: | July 24, 2006 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00356681 History of Changes |
| Health Authority: | Australia: Therapeutic Goods Administration; France: Agence française de sécurité sanitaire des produits de santé; Germany: Bundesinstitute für Arzneimittel und Medizinprodukte; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Ireland: Irish Medicines Board; New Zealand: Ministry of Health, Medicines and Medical Devices Safety Authority; Poland: Office for Medicinal Products; Spain: Agencia española del medicamento; United States: Food and Drug Administration |
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Paclitaxel Metastatic Breast Cancer Antiangiogenic Bevacizumab AMG 706 |
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Skin Diseases Paclitaxel Tubulin Modulators Breast Neoplasms Antimitotic Agents |
Bevacizumab Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Breast Diseases Recurrence |
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Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Breast Neoplasms Bevacizumab Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Breast Diseases |