Status:
COMPLETED
Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma
Lead Sponsor:
Vector Oncology
Collaborating Sponsors:
Novartis
Conditions:
Liposarcoma
Surgically Unresectable Liposarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
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 (RECIS...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01506596
Start Date
March 1 2012
End Date
March 1 2016
Last Update
February 15 2017
Active Locations (9)
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1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
2
Washington Cancer Institute
Washington D.C., District of Columbia, United States, 20010
3
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
4
Oncology Specialists, SC
Niles, Illinois, United States, 60714