NCT07104331 SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma

Trial Parameters

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Brief Summary

This is a non-randomized, open label, single arm Phase II trial with a two-stage design with histologically-confirmed metastatic and/or recurrent epithelioid hemangioendothelioma requiring systemic treatment. nab-Sirolimus 100 mg/m2 will be administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary objective is to determine ORR by RECIST v1.1 of nab-sirolimus in patients with EHE who require systemic treatment.

Eligibility Criteria

Inclusion Criteria: * Participants must have histologically or cytologically confirmed EHE that is either progressing or clinically symptomatic, not a candidate for curative intent surgery, and requires systemic therapy in the opinion of the investigator. * Participants must have measurable disease by RECIST v1.1, 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 (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease. * Age ≥18 years * ECOG performance status ≤2 * Participants must meet the following organ and marrow function as defined below: * Platelets \>75,000μl * ANC \>1500μl * Hgb \>9g/dl * Creatinine \<1.5 x ULN or measured CrCl of \>30ml/m2/1.73 m2 * Total bilirubin \<2 x ULN * AST/ALT \<3 x ULN * Patients must have recovered

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