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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.

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer

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Trial Information

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.

This study will be conducted in patients with metastatic cancer and either moderate, severe
or no hepatic impairment who have failed other antineoplastic therapies or for whom there is
no standard therapy. The study will be conducted in two stages. Stage I will include
patients with moderate hepatic impairment and Stage II will include patients with severe
hepatic impairment. An analysis of data from the Stage I portion of the study will be
performed to decide whether to enroll patients in the Stage II portion of the study.
Patients with hepatic impairment (either moderate or severe) will be paired with matched
control patients with normal hepatic function, matched on gender, age, and body surface are
(BSA). Patients will receive a single dose of pixantrone on day 1 of a 21 day cycle. Blood
samples will be obtained at various time points during the first week of the first cycle for
pharmacokinetic (PK) analysis. If any patient with hepatic impairment develops a dose
limiting toxicity, subsequent patients will be administered a lower dose of pixantrone. If
any patient with hepatic impairment who is receiving the reduced dose of pixantrone
experiences a dose limiting toxicity, the study will be terminated. Patients who
demonstrate any clinical, radiologic, or other evidence of response or stabilization after
the initial dose of pixantrone and who wish to continue treatment may do so at the
discretion of the Investigator. Patients receiving additional cycles will be treated with
pixantrone every 21 days for up to 5 additional cycles and will be followed for safety only,
until 30 days after the last dose.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

The following pharmacokinetic parameters will be calculated; CL, Cmax, AUC-Steady State, Tmax, T 1/2, AUCo-TLAST.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

John Sarantopoulos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UTHSCSA- Cancer Therapy & Research Center


United States: Food and Drug Administration

Study ID:

PIX 112



Start Date:

May 2012

Completion Date:

February 2018

Related Keywords:

  • Metastatic Cancer
  • Hepatic impairment
  • Metastatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Diseases



UTHSCSA-Cancer Therapy-Research Center San Antonio, Texas  78229