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PTC299
PTC299 for Treatment of Advanced Cancer
Ensayo de PTC THERAPEUTICS, INC. en Cancer avanzado.
Más ensayos de: Cáncer avanzado.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 76
- Centros
- 1
- Fin del objetivo primario
- feb 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2008.
Qué mide
Maximum Tolerated Dose (MTD) of PTC299 within the tested dose range. (del registro, en inglés) (6 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroFormation of new blood vessels (angiogenesis) is important for tumor growth in advanced cancer. It is known that tumors make a protein called vascular endothelial growth factor (VEGF). VEGF stimulates the formation of blood vessels that supply the tumor with nutrients and oxygen. PTC299 is an oral investigational new drug that has been shown to decrease production of VEGF in animal models of human cancer. In these animal models, oral PTC299 administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood vessel numbers in the tumor, and significantly slows or halts tumor growth. When given in combination with the chemotherapeutic drug, docetaxel, PTC299 increases the antitumor activity over use of docetaxel alone. Safety studies in research animals indicate good tolerability at doses and drug levels that are higher than those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active in animal models of human cancer. This Phase 1b study is designed to test the hypothesis that PTC299 will be tolerable and will show evidence of anti-VEGF and antitumor activity when administered orally to participants with cancer.
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Todos los de PTCT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00704821), actualizada en may 2019.