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LiposarcomaPhase 2NCT01506596

Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

A Phase 2 study testing pazopanib in people with Liposarcoma and Surgically Unresectable Liposarcoma, run by Vector Oncology at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
9 sitesUnited States
Study dates
Mar 2012to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Written informed consent.
  • Age > or = to 18 years.
  • Histologically or cytologically confirmed high- or intermediate-grade liposarcoma (allowed subtypes include liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, or not otherwise specified).
  • Surgically unresectable or metastatic disease.
  • Any number of prior treatment treatment regimens, including treatment naive subjects.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1. Subjects must have documented disease progression within the past 6 months.
  • Adequate organ system function determined within 14 days prior to first dose of study treatment.
  • Left ventricular ejection fraction (LVEF) > 50% of the institutional LLN within 28 days prior to the first dose of study treatment.
  • Females must be of either non-child bearing potential or have a negative pregnancy test within 7 days prior to the first dose of study treatment.

Who cannot join

  • Well differentiated liposarcoma.
  • Prior treatment with tyrosine kinase inhibitors (TKIs) or vascular endothelial growth factor (VEGF) inhibitors.
  • Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).
  • History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first dose of study drug
  • Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.
  • Clinically significant GI abnormalities that may affect absorption of investigational product.
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  • Presence of uncontrolled infection.
  • Corrected QT interval > 480 msecs using Bazett's formula.
  • History of certain cardiovascular conditions within the past 6 months.
  • Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg].
  • History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep vein thrombosis within the past 6 months.
  • Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding diathesis.
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
  • Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug, whichever is longer, prior to the first dose of study drug and for the duration of study treatment.
  • Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug.
  • Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study drug.
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
  • Known immediate or delayed hypersensitivity reaction to idiosyncrasy to drugs chemically realted to pazopanib or excipients that contraindicates participation.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • West Clinic

    Memphis, Tennessee, 38120

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Oncology Specialists, SC

    Niles, Illinois, 60714

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.

Read the detailed description

This is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.

Being tested
pazopanib
Keywords
Liposarcoma
Medical subject headings
Liposarcoma

What participants receive

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

  • pazopanibDrug

    Also called Votrient

    Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.

Study groups in NCT01506596
Study groupRoleWhat they receive
pazopanibExperimentalPazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Receives: Drug: pazopanib

What is being measured

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

  1. 12-week Progression Free Rate

    Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.

    Measured: Assessed after 12 weeks of study treatment

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.

    Measured: Date of Consent until progression or death, up to 27 months

  2. Best Overall Response

    Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Measured: Date of consent until end of study treatment, up to 32 months

  3. Duration of Response

    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.

    Measured: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression

  4. Overall Survival (OS)

    OS was measured from date of consent until time of death from any cause, up to 32 months.

    Measured: Date of Consent until death, up to 32 months

Timeline

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

  1. First posted10 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2014
  4. Study completionMar 2016

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506596
Sponsor's protocol ID
ABLSMLS1101
Status last verified
Mar 2016
First submitted
6 Jan 2012
Last updated
15 Feb 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib in people with Liposarcoma and Surgically Unresectable Liposarcoma, run by Vector Oncology at 9 sites 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

12-week Progression Free Rate (time frame: Assessed after 12 weeks of study treatment). 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 NCT01506596.

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 15 Feb 2017.

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