NCT03660930

Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas

A Phase 1/2 Study of Nab-Sirolimus With Pazopanib (VOTRIENT®) in Patients With Advanced Nonadipocytic Soft-Tissue Sarcomas

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of nab-sirolimus and how well it works when given together with pazopanib hydrochloride in treating participants with nonadipocytic soft tissue sarcomas that has spread to other places in the body (advanced). Nab-sirolimus and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

OUTLINE: This is a phase I, dose-escalation study of nanoparticle albumin-bound rapamycin followed by a phase II study. Participants receive nab-sirolimus intravenously (IV) on days 1 and 8 or day 1 only and pazopanib hydrochloride orally (PO) daily on days 1-21. Cycles repeat every 21 days until unequivocal clinical disease progression, unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at the patient's discretion. After completion of study treatment, participants are followed up at 30 days, then every 12 weeks.

Conditions

• Advanced Soft Tissue Sarcoma
• Locally Advanced Soft Tissue Sarcoma
• Metastatic Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Sirolimus Albumin-bound Nanoparticles	Given IV
DRUG	Pazopanib hydrochloride	Given PO

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-11-17
• Completion: 2024-07-31
• First posted: 2018-09-07
• Last updated: 2025-04-30
• Results posted: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study