Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors

Inclusion Criteria

• •1. Age ≥ 18 years
• •2. Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available.
• •3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• •4. Normal organ and marrow function as defined below within 14 days of study entry
• •1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• •2. Platelet count ≥100 x 109/L
• •3. Hemoglobin ≥ 9 g/dL
• •4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• •5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), or 5 x ULN for subjects with liver metastases
• •6. Serum creatinine ≤ 1.5 x ULN or calculated estimated creatinine clearance ≥ 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal based on the Cockcroft and Gault formula.
• •5. Never received prior TLI or topotecan HCl (Hycamtin®)
• •6. At least 4 weeks must have elapsed from the last dose of chemotherapy.
• •7. Life expectancy ≥ 3 months
• •8. Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
• •9. If female, subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation.
• •10. If male, subject agrees to use an acceptable barrier method for contraception from the screening visit though the duration of study participation.
• •11. Before enrollment, the subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign a written informed consent according to ICH/GCP, and national/local regulations.