A Non-randomized Cohort Study With Matched Controls Investigating Pharmacokinetic Parameters and Safety of a Single Dose of Pixantrone With Metastatic Cancer and Moderate, Severe, or No 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