This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor

Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Patrocinadores

Patrocinador principal: Sigma-Tau Research, Inc.

Colaborador: Rhode Island Hospital
Dana-Farber Cancer Institute

Fuente Sigma-Tau Research, Inc.
Resumen breve

Gimatecan® is sigma-tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound, when given as a capsule, rather than by intravenous injection.

Estado general Completed
Fecha de inicio March 2002
Fecha de Terminación February 2005
Fase Phase 1
Tipo de estudio Interventional
Inscripción 30
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Gimatecan® (ST-1481)

Elegibilidad

Criterios:

Inclusion criteria:

- Histologically/cytologically proven advanced solid tumors

- Life expectancy of at least 3 months with normal hematological, liver and renal function

Exclusion criteria:

- Pregnant and lactating patients

- Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy

- Gastrointestinal dysfunction that could alter absorption or motility

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute | Boston, Massachusetts, 02115, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
Ubicacion Paises

United States

Fecha de verificación

June 2009

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov