Trials / Recruiting
RecruitingNCT07104331
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- Sponsor
- Sarcoma Alliance for Research through Collaboration · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-Sirolimus | 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. |
Timeline
- Start date
- 2026-02-24
- Primary completion
- 2029-08-30
- Completion
- 2029-08-30
- First posted
- 2025-08-05
- Last updated
- 2026-03-03
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07104331. Inclusion in this directory is not an endorsement.