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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The following pharmacokinetic parameters will be calculated; CL, Cmax, AUC-Steady State, Tmax, T 1/2, AUCo-TLAST.
John Sarantopoulos, MD
UTHSCSA- Cancer Therapy & Research Center
United States: Food and Drug Administration
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