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| ID | Type | Description | Link |
|---|---|---|---|
| CIRG/TORI 010 |
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Sponsor decision to close study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A Placebo | Placebo Comparator | Blinded AMG 706 placebo plus paclitaxel |
|
| Arm B Experimental | Experimental | Blinded AMG 706 plus paclitaxel |
|
| Arm C Comparator | Active Comparator | Open-label bevacizumab plus paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 706 placebo | Drug | Blinded placebo |
| |
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate, measured radiologically and assessed by an independent review committee. | Last patient enrolled + 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21429799 | Derived | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Drug |
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody. |
|
|
| AMG 706 | Drug | 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 | Drug | Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000625785 | motesanib diphosphate |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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