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

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.