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Nab-Sirolimus with Pazopanib in Advanced Nonadipocytic Soft-Tissue Sarcomas
NCT03660930Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2019
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- University of Washington
- Modality
- Nanoparticles, Small Molecules
- Drugs
- nab-sirolimus
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label, single-arm trial of nab-sirolimus in soft tissue sarcoma (STS), sponsored by University of Washington. Primary endpoints: Maximum-tolerated Dose of Nab-rapamycin, Maximum-tolerated Dose of Pazopanib and 2 more. Started Apr 2019; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment (ABI-009, pazopanib)
Nab-sirolimus + Pazopanib
03
Who it enrols
Adult patients with histologically confirmed advanced non-adipocytic soft tissue sarcoma who have progressed on at least one prior systemic regimen.
04
Endpoints
Primary
Maximum-tolerated Dose of Nab-rapamycin
Maximum-tolerated Dose of Pazopanib
Dose-Limiting Toxicities
Progression-free Survival Rate
Secondary
Incidence of Adverse Events Profile
Median Progression-free Survival
Progression-Free Survival Rate
Median Overall Survival
Overall Survival Rate
Objective Response Rate
Disease Control Rate
Duration of Response
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