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defactinib

Phase I/Ib Study of Paclitaxel in Combination With VS-6063 in Patients With Advanced Ovarian Cancer

Ensayo de Verastem, Inc. en Cancer de ovario.

Más ensayos de: Cáncer de ovario.

Fase

Fase 1

Estado

Completado

Participantes

22

previstos

Centros

3

Fin del objetivo primario

feb 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en feb 2013.

Qué mide

Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.03 (Common Toxicity Criteria for Adverse Effects)during the study (safety and tolerability). (From start of treatment to end of treatment, an expected average of 12 weeks) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063) when administered in combination with paclitaxel. Pharmacodynamic effects will also be examined in tumor biopsies.

Más ensayos de VSTM

Todos los de VSTM, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01778803), actualizada en may 2017.