The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Sarcoma Oncology Center
Santa Monica, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Oncology Specialists, SC
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.
Time frame: Assessed after 12 weeks of study treatment
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.
Time frame: Date of Consent until progression or death, up to 27 months
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.
Time frame: Date of consent until end of study treatment, up to 32 months
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Niles, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Minnesota
Minneapolis, Minnesota, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
West Clinic
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression
Overall Survival (OS)
OS was measured from date of consent until time of death from any cause, up to 32 months.
Time frame: Date of Consent until death, up to 32 months