Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

Inclusion Criteria

• Age ≥18 years male or female.
• Histological confirmation of SCLC.
• Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
• Capable of providing informed consent and complying with trial procedures.
• ECOG PS 0-2.
• Life expectancy >8 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.[22]
• Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
• Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Exclusion Criteria

• Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
• Prior treatment with topotecan.
• Palliative surgery and/or radiation treatment 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) 16 meq/L or arterial blood pH class II of the New York Heart Association (NYHA) guidelines (Appendix D).
• Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
• Baseline QTc >470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
• History or signs of active coronary artery disease with angina pectoris within the last 6 months.
• Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
• Known history of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
• Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
• Major surgery within 30 days prior to date of randomization.
• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the subject's participation in the study.