A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

Inclusion Criteria:

• Written informed consent
• Patients with confirmed advanced solid tumors.
• No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
• At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
• Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria:

• Women who are pregnant or lactating.
• Patients of child bearing potential refusing to practice adequate contraception.
• Patients with uncontrolled vomiting.
• Active infection.
• Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
• Patients requiring treatment with cyclosporin A.
• Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
• Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
• Use of investigational drug within 30 days prior to the first dose of study medication.