The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
This research study is being conducted in adult subjects with a type of bone cancer called chondrosarcoma that has spread to other parts of the body and is not able to be removed with surgery. There is only one study drug that will be used in this study. It is a drug that interferes with cell communication and growth, taken orally. The study drug is called pazopanib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
City of Hope
Duarte, California, United States
Edward Cancer Center
Naperville, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Mayo Clinic
Rochester, Minnesota, United States
Disease Control at Week 16
Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).
Time frame: Assessed at week 16 of study treatment
Progression Free Survival (PFS)
The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks). No upper limits of duration of assessment are identified or defined in the protocol.
Time frame: Cycle 1 day 1 until the subject experiences disease progression
Overall Survival (OS)
The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.
Time frame: Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent
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Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Edgbaston, Birmingham, United Kingdom