SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Part of paid clinical trials in Stanford, California.
- Sponsor
- Sarcoma Alliance for Research through Collaboration
- Study ID
- NCT07104331
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Epithelioid Hemangioendothelioma (EHE)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- nab-Sirolimus — DRUGnab-Sirolimus 100 mg/m2 will be administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle.
Study Details
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.
Key Dates
- Start date
- Feb 24, 2026
- Status verified
- May 2026
- Primary completion
- Aug 30, 2029
- Completion
- Aug 30, 2029
Study Design
- Enrollment
- 41 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: non-randomized, open label, single arm
Primary Outcome Measure
Tumor response rate [ Time Frame: Approximately 24 months ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | |
| University of Colorado | Aurora | Colorado | 80203 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Michael Wagner, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University St. Louis | St Louis | Missouri | 63130 | |
| Sloan Kettering Institute for Cancer Research | New York | New York | 10065 |