A Phase 1 Study of S-3304 in Patients With Solid Tumors

A Phase 1 Study of S-3304 in Patients With Solid Tumors

Patrocinadores

Patrocinador principal: Shionogi

Fuente Shionogi Inc.
Resumen breve

To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population

Estado general Completed
Fecha de inicio November 2001
Fecha de Terminación March 12, 2003
Fecha de finalización primaria February 13, 2003
Fase Phase 1
Tipo de estudio Interventional
Inscripción 32
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: S-3304

Elegibilidad

Criterios:

Inclusion criteria:

- Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s)

- Must be able to tolerate oral medication Exclusion criteria

- Patients with other serious illnesses

- Patients who are receiving treatments

Género: All

Edad mínima: 18 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Ubicación
Instalaciones:
University of Colorado Hospital | Denver, Colorado, 80262, United States
H. Lee Moffitt Concer Center and Research Institute | Tampa, Florida, 33612, United States
Roswell Park Cancer Center | Buffalo, New York, 14263, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
Ubicacion Paises

United States

Fecha de verificación

April 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Sequential Assignment

Descripción del modelo de intervención: Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov