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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2012
End Date:June 2016

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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.


Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.
We found this trial at
9
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Houston, Texas 77030
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100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Niles, Illinois 60714
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Philadelphia, Pennsylvania 19106
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Post Falls, Idaho 83854
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Santa Monica, California 90403
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Washington, District of Columbia 20010
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Washington,
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