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

NCT01632436 | Withdrawn Phase 1

• 1 other identifier: PIX 112
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. Using an existing pixantrone population pharmacokinetic (PPK) model, a model-based strategy will be used to evaluate the findings from the first stage of the study conducted in patients with moderate hepatic impairment and matched controls. The PPK evaluation will be completed prior to enrolling patients with severe hepatic impairment and additional matched controls during the second stage of the study. Patients with hepatic impairment will be paired with matched control patients with normal hepatic function, matched on gender, age, and body surface area (BSA).

Conditions

Metastatic Cancer

Keywords

Hepatic impairment; Metastatic Cancer

Outcome Measures

Primary Outcomes (3)

• Cmax

  Cmax ratio of patients with hepatic impairment / matched control (geometric mean and 90% confidence interval)

  Day 1 Cmax

• Clearance

  Clearance ratio of patients with hepatic impairment / matched control (geometric mean and 90% confidence interval)

  Day1-7

• AUC

  AUCss ratio of patients with hepatic impairment / matched control (geometric mean and 90% confidence interval)

  Day 1-7

Secondary Outcomes (1)

• Incidence of Adverse Events

  Day 1-7

Study Arms (2)

Stage 1 -Moderate Hepatic Impairment

EXPERIMENTAL

Pixantrone

Drug: Pixantrone

Stage 2 - Severe Hepatic Impairment

EXPERIMENTAL

Pixantrone

Drug: Pixantrone

Interventions

Pixantrone DRUG

Experimental Drug

Stage 1 -Moderate Hepatic Impairment; Stage 2 - Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Institutional Review Board (IRB) approved consent form
• Age ≥ 18 years old
• Histological confirmation of cancer from any previous cytological or tissue report
• Diagnosis of metastatic disease based on biopsy, imaging, or clinical criteria
• Failure of other antineoplastic therapies, or disease for which no standard therapy exists
• At least 28 days since last antineoplastic therapy
• ECOG PS ≤ 2 (see Appendix 8.2)
• Life expectancy ≥ 12 weeks in Investigator's judgment
• LVEF ≥ 50% by echocardiogram
• Hemoglobin ≥ 8 g/dL (can be post transfusion)
• Platelets ≥ 75 x 109/L
• ANC \> 1.5x109/L
• 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
• Serum creatinine ≤ 1.0 x ULN
• All acute toxicities related to prior treatment recovered to grade ≤ 1 or baseline except alopecia

You may not qualify if:

• Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m² according to the calculation index in Appendix 8.1
• Total serum bilirubin \> 4.0 ULN
• LVEF \< 50% by echocardiogram
• Active grade 3/4 infection
• Major surgery ≤ 28 days prior to first dose
• Gilbert's syndrome
• Known human immunodeficiency virus
• Any antineoplastic therapy ≤ 28 days prior to first dose
• New York Heart Association Classification III or IV heart disease (see Appendix 8.3)
• Any contraindication or known allergy or hypersensitivity to the study drug
• Pregnant or lactating
• Concomitant therapy with anticancer agents (corticosteroid use is permitted)
• Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study procedures or follow-up schedule
• 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

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (1)

UTHSCSA-Cancer Therapy-Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pixantrone

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Sarantopoulos, MD

  UTHSCSA- Cancer Therapy & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: July 3, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

US (1)