Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

Inclusion criteria:

• Advanced or metastatic cancer
• 18 years and above

Exclusion criteria:

• Previous treatment with 4 or more cycles of carboplatin;
• Previous treatment with 2 or more courses of nitrosourea or mitomycin;
• Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
• Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply