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neratinib

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

Ensayo de PUMA BIOTECHNOLOGY, INC. en Breast Cancer · Advanced Malignant Solid Tumors (del registro, en inglés).

Más ensayos de: Cáncer de mama.

Fase

Fase 1/2

Estado

Completado

Participantes

92

previstos

Centros

35

Fin del objetivo primario

oct 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2008.

Qué mide

Overall Response Rate (From first dose date to progression or last tumor assessment, up to four years and six months.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.

Más ensayos de PBYI

Todos los de PBYI, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00706030), actualizada en jul 2018.