AzTrials
AzTrials

Metastatic CancerPhase 1HepaticNCT01632436

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

A Phase 1 study testing Pixantrone in people with Metastatic Cancer, run by CTI BioPharma at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer
What is being tested?
Pixantrone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2012to Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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
  • Willingness and ability to comply with the visit schedule and assessments required by the study protocol
  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UTHSCSA-Cancer Therapy-Research Center

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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. 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).

Read the detailed description

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.

Being tested
Pixantrone
Keywords
Hepatic impairment, Metastatic Cancer
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PixantroneDrug

    Experimental Drug

Study groups in NCT01632436
Study groupRoleWhat they receive
Stage 1 -Moderate Hepatic ImpairmentExperimentalPixantrone
Receives: Drug: Pixantrone
Stage 2 - Severe Hepatic ImpairmentExperimentalPixantrone
Receives: Drug: Pixantrone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

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

    Measured: Day 1 Cmax

  2. Clearance

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

    Measured: Day1-7

  3. AUC

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

    Measured: Day 1-7

Secondary outcomes (1)

  1. Incidence of Adverse Events

    Safety and tolerability of pixantrone, including monitoring of adverse events (AEs); an AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage

    Measured: Day 1-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2017
  4. Study completionFeb 2018

Why it stopped: No eligible patients enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632436
Sponsor's protocol ID
PIX 112
Acronym
Hepatic
Status last verified
Sep 2023
First submitted
27 Jun 2012
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pixantrone in people with Metastatic Cancer, run by CTI BioPharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 Cmax). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in