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

Sigma-Tau Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Malignancies

Treatments: Drug: Gimatecan® (ST-1481)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00033202

ST 01-401

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)