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POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POL6326 | Experimental | POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL6326 | Drug | POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer | Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer | Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin | 12-24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's Cancer Institute | Kansas City | Kansas | 64111 | United States | ||
| Washington University School of Medicine, Division of Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29706375 | Derived | Pernas S, Martin M, Kaufman PA, Gil-Martin M, Gomez Pardo P, Lopez-Tarruella S, Manso L, Ciruelos E, Perez-Fidalgo JA, Hernando C, Ademuyiwa FO, Weilbaecher K, Mayer I, Pluard TJ, Martinez Garcia M, Vahdat L, Perez-Garcia J, Wach A, Barker D, Fung S, Romagnoli B, Cortes J. Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial. Lancet Oncol. 2018 Jun;19(6):812-824. doi: 10.1016/S1470-2045(18)30147-5. Epub 2018 Apr 26. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000624271 | balixafortide |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| 'Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Weill Cornell Breast Center | New York | New York | 10065 | United States |
| Vanderbilt University School of Medicine | Nashville | Tennessee | 37232 | United States |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Quiron Barcelona | Barcelona | 08023 | Spain |
| Hospital Vall d'Hebrón | Barcelona | 08035 | Spain |
| Instituto Catalàn de Oncologia L'Hospitalet | L'Hospitalet de Llobregat | 08908 | Spain |
| HGUG Marañón | Madrid | 28007 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Cinico Universitario de ValenciaValencia | Valencia | 46010 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |