Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment

Inclusion Criteria:

1. Signed Institutional Review Board (IRB) approved consent form
2. Age ≥ 18 years old
3. Histological confirmation of cancer from any previous cytological or tissue report
4. Diagnosis of metastatic disease based on biopsy, imaging, or clinical criteria
5. Failure of other antineoplastic therapies, or disease for which no standard therapy exists
6. At least 28 days since last antineoplastic therapy
7. ECOG PS ≤ 2 (see Appendix 8.2)
8. Life expectancy ≥ 12 weeks in Investigator's judgment
9. LVEF ≥ 50% by echocardiogram
10. Hemoglobin ≥ 8 g/dL (can be post transfusion)
11. Platelets ≥ 75 x 109/L
12. ANC \> 1.5x109/L
13. Stage I, moderate hepatic impairment: 1.5 \< total serum bilirubin ≤ 3.0 ULN Stage II, severe hepatic impairment: 3.0 \< total serum bilirubin \< 4.0 ULN Stages I and II, normal liver function: total bilirubin \< 1.0 ULN
14. Serum creatinine ≤ 1.0 x ULN
15. All acute toxicities related to prior treatment recovered to grade ≤ 1 or baseline except alopecia
16. Willingness and ability to comply with the visit schedule and assessments required by the study protocol
17. If fertile, both males and females must agree to use appropriate and effective contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the duration of study participation and for 6 months after last dose of study drug.

Exclusion Criteria:

1. Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m² according to the calculation index in Appendix 8.1
2. Total serum bilirubin \> 4.0 ULN
3. LVEF \< 50% by echocardiogram
4. Active grade 3/4 infection
5. Major surgery ≤ 28 days prior to first dose
6. Gilbert's syndrome
7. Known human immunodeficiency virus
8. Any antineoplastic therapy ≤ 28 days prior to first dose
9. New York Heart Association Classification III or IV heart disease (see Appendix 8.3)
10. Any contraindication or known allergy or hypersensitivity to the study drug
11. Pregnant or lactating
12. Concomitant therapy with anticancer agents (corticosteroid use is permitted)
13. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study procedures or follow-up schedule
14. Severe and/or uncontrolled medical disease that could compromise participation in the study or any medical or psychiatric condition that in the opinion of the Investigator would make study drug administration hazardous or obscure the interpretation of data