A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors

Inclusion criteria

• Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists
• Life expectancy of at least 3 months
• No dysfunction of bone marrow
• No major impairment of renal and hepatic function

Exclusion criteria

• Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
• Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
• Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
• Patients known to be HIV, or hepatitis B or C viruses positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
• Patients with a history of allergies to the camptothecin family of drugs

Other protocol-defined inclusion/exclusion criteria may apply