|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
| Enrollment: | 282 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
Blinded AMG 706 placebo
|
Drug: AMG 706 placebo
AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
|
|
Active Comparator: B
Blinded AMG 706
|
Drug: AMG 706
AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity
|
|
Experimental: C
Open-label bevacizumab
|
Drug: Bevacizumab
Bevacizumab 10 mg/kg IV every 14 days until disease progression, consent withdrawal or unacceptable toxicity
Other Name: Avastin
|
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: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00356681 History of Changes |
| Other Study ID Numbers: | 20050225, CIRG/TORI 010 |
| Study First Received: | July 24, 2006 |
| Last Updated: | September 1, 2011 |
| 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 |
|
AMG 706 Paclitaxel Metastatic Breast Cancer Antiangiogenic Bevacizumab |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Paclitaxel Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |