Calendario›SNY›XL147
XL147
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 42
- Centros
- 9
- Fin del objetivo primario
- dic 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2010.
Qué mide
Safety and tolerability of XL147 in combination with trastuzumab and in combination with trastuzumab and paclitaxel (safety assessments at weekly study visits) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPhase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel. After the MTD is established for each combination (Phase 2), subjects will be enrolled to evaluate the preliminary efficacy and safety of these combinations in metastatic HER2 positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of metastatic breast cancer (MBC), but patients can develop resistance. The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of PI3K has been shown to transform and confer paclitaxel resistance to immortalized breast epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147 may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01042925), actualizada en may 2016.