A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (NCT03544567) | Clinical Trial Compass
CompletedPhase 2
A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
United States, Hong Kong48 participantsStarted 2018-12-21
Plain-language summary
This is a non-blinded, multi-center, open-label, phase 2 study to evaluate the activity, safety, and tolerability of Oraxol in subjects with cutaneous angiosarcoma.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Willingness and ability to give informed consent, prior to any study-specific procedures and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Age of 18 years or older
* Histologically-confirmed cutaneous angiosarcoma that is not amenable to curative intent surgery (eg, locally advanced disease and disease for which surgical resection would carry an unacceptable risk of recurrence or morbidity to the subject)
* Subjects who have not received taxanes for the treatment of angiosarcoma
* Measurable disease per RECIST v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade ≤1 or to that subject's baseline
* Adequate organ function as defined by the following criteria:
* Adequate renal function as evidenced by serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min per the Cockcroft and Gault formula
* Adequate bone marrow function as evidenced by:
* absolute neutrophil count (ANC) ≥1.5 × 109/L
* hemoglobin ≥9.0 g/dL (\<9.0 g/dL is acceptable if it is corrected by transfusion), and
* platelet count ≥100 × 109/L
* Adequate liver function as evidenced by
* total bilirubin within normal limits,
* alanine aminotransferase (ALT) ≤3×ULN, and as…