Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma (NCT02048722) | Clinical Trial Compass
CompletedPhase 2
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
United States31 participantsStarted 2014-06-13
Plain-language summary
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Life expectancy of at least 4 months
* Histologically confirmed angiosarcoma
* Tumor deemed unresectable or metastatic
* Measurable disease per RECIST v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Progressive disease under last palliative therapy with a history of prior ifosfamide, doxorubicin or taxane therapy for angiosarcoma; up to 4 prior therapies are allowed
* All acute toxic effects of any prior treatment have resolved to grade 1 or less (by National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v 4.0) at the time of registration; NOTE: Exceptions to this criterion will include alopecia and fatigue
* Total bilirubin =\< 1.5 x the upper limits of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
* Alkaline phosphatase limit =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
* Lipase =\< 1.5 x the ULN
* Serum creatinine =\< 1.5 x the ULN
* International normalized ratio (INR)/partial thromboplastin time (PTT) \< 1.5 x ULN
* Platelet count \> 100000/mm\^3
* Hemoglobin \> 9 g/dL
* Absolute neutrophil count \> 1500/mm\^3
* If baseline urine protein creatinine (UPC) \>= 1, a 24-hour urine protein must be assessed; patients must have a 24-hour urine protein value \< grade 3 (\> 3.5 g/24 hours) to be eligible
* NOTE: Blood transfusion to meet the ā¦