Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma
This trial is active, not recruiting.
|Conditions||liposarcoma, surgically unresectable liposarcoma, metastatic liposarcoma|
|Targets||VEGF, KIT, PDGF|
|Start date||March 2012|
|End date||October 2015|
|Trial size||42 participants|
|Trial identifier||NCT01506596, ABLSMLS1101|
The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Santa Monica, CA||Sarcoma Oncology Center||no longer recruiting|
|Washington, DC||Washington Cancer Institute||no longer recruiting|
|Post Falls, ID||Kootenai Cancer Center||no longer recruiting|
|Niles, IL||Oncology Specialists, SC||no longer recruiting|
|Iowa City, IA||University of Iowa||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Philadelphia, PA||Pennsylvania Oncology Hematology Associates||no longer recruiting|
|Memphis, TN||West Clinic||no longer recruiting|
|Houston, TX||MD Anderson Cancer Center||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
12-week Progression Free Rate
time frame: Assessed after 12 weeks of study treatment
Progression free survival (PFS)
time frame: Cycle 1 Day 1 until the subject experiences disease progression
Response rate (RR)
time frame: Cycle 1 Day 1 until end of study treatment
Duration of response
time frame: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression
Overall survival (OS)
time frame: Cycle 1 Day 1 up to 24 months after the end of study treatment
Male or female participants at least 18 years old.
- 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.
- 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.
|Official title||A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma|
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