Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE) (NCT03331250) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
United States13 participantsStarted 2018-01-18
Plain-language summary
This research study is studying a drug as a possible treatment for Angiosarcoma or Epithelioid hemangioendothelioma (EHE).
-The drug involved in this study is Eribulin
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Metastatic or locally advanced angiosarcoma, treated with at least one prior systemic therapy where no standard of care curable therapy is available OR metastatic or locally advanced malignant and progressive epithelioid hemangioendothelioma (EHE).
* A maximum of 5 EHE patients will be accrued on this study
* Archival tissue confirming the diagnosis must be reviewed by BWH/DFCI/MGH pathology.
* Progression on at least one prior systemic therapy or progression during an observation phase of no anti-cancer therapy within the prior 3 months; prior taxanes are allowed
* Participants must have measurable disease by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
* Age \> 18 years.
* ECOG performance status ≤2
* Life expectancy of greater than 3 months
* Participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,000/mcL
* platelets ≥100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
* Baseline QTcF \< grade 2
* The effects of Eribulin on the devel…