Actively Recruiting
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Led by Sarcoma Alliance for Research through Collaboration · Updated on 2026-03-03
41
Participants Needed
6
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed epithelioid hemangioendothelioma (EHE) that is progressing or clinically symptomatic
- Not a candidate for curative surgery and requires systemic therapy as determined by the investigator
- Measurable disease by RECIST v1.1 criteria
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function: platelets >75,000/µl; ANC >1500/µl; hemoglobin >9 g/dl; creatinine <1.5 times upper limit of normal or creatinine clearance >30 ml/min/1.73 m2; total bilirubin <2 times upper limit of normal; AST/ALT <3 times upper limit of normal
- Recovery from prior therapy toxicities to grade ≤1 (except alopecia, neuropathy, or immunotherapy-related hypothyroidism)
- Agreement to use adequate contraception before, during, and for 4 months after study treatment for patients of childbearing potential
- Negative serum pregnancy test within 7 days of enrollment for females of childbearing potential
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Active and uncontrolled infection, NYHA Class III-IV congestive heart failure, Child's class B-C cirrhosis, or other uncontrolled medical disease compromising safety or efficacy assessment
- Active hepatitis B or C infection; positive PCR test for hepatitis B or C
- HIV infection with CD4 count ≤200, detectable viral load, or AIDS-defining illness within 12 months; antiviral regimen containing strong CYP3A4 inhibitors
- Major surgery or open surgical biopsy within 28 days before first study drug dose
- Active central nervous system disease or prior Grade ≥3 CNS drug-related toxicity; stable treated CNS metastases without steroids allowed
- Psychiatric or substance abuse disorders interfering with study cooperation
- Myocardial infarction within 12 months before screening
- Other concurrent malignancies or use of other investigational or anticancer agents except certain hormonal therapies
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Stanford University
Stanford, California, United States, 94305
Not Yet Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80203
Not Yet Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Washington University St. Louis
St Louis, Missouri, United States, 63130
Not Yet Recruiting
6
Sloan Kettering Institute for Cancer Research
New York, New York, United States, 10065
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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