This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.

Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

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. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.

Inclusion criteria:

• Histologically confirmed diagnosis of a recurrent primary malignant glioma
• 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