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

Sigma-Tau Research, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Malignancies

Interventions

Gimatecan® (ST-1481)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Data from ClinicalTrials.gov

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