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.

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.

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