Nab-Sirolimus + Pazopanib for Soft Tissue Sarcoma

Overseen By Roxanne Moore

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Washington

Must be taking: Pazopanib

Must not be taking: mTOR inhibitors, Angiogenesis inhibitors

Disqualifiers: CNS metastases, Severe hepatic impairment, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 21-day cycles, up to 41 weeks

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lee Cranmer

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Adults (18+) with advanced nonadipocytic soft tissue sarcomas not suitable for surgery or curative treatments, who haven't had more than four systemic therapies. Participants must have manageable cholesterol and triglyceride levels, normal heart function, adequate blood counts, and no major organ dysfunction. They should not be pregnant or breastfeeding and must agree to use effective contraception.

Inclusion Criteria

Hemoglobin >= 9 g/dL.

Serum cholesterol =< 350 mg/dL.

Ability to understand and sign informed consent.

Exclusion Criteria

I don't have major stomach or bowel issues that could affect medication absorption.

My brain metastases are controlled, not currently treated with steroids, and I finished any brain treatment over 28 days ago.

My diabetes is not under control, with HbA1c levels over 8% despite treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nab-sirolimus intravenously on days 1 and 8 or day 1 only and pazopanib hydrochloride orally daily on days 1-21. Cycles repeat every 21 days until disease progression or unacceptable toxicity.

21-day cycles, up to 41 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion at 30 days, then every 12 weeks.

Up to 2 years

Treatment Details

Interventions

• Pazopanib hydrochloride
• Sirolimus Albumin-bound Nanoparticles

Trial Overview The trial is testing the combination of nab-sirolimus (a drug that targets cancer cell growth) with pazopanib hydrochloride (which blocks enzymes needed for tumor growth) in patients with advanced soft tissue sarcoma. The study aims to determine the best dose and assess how well these drugs work together.

Participant Groups

Group I: Treatment (ABI-009, pazopanib) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Aadi Bioscience, Inc.

Industry Sponsor

Trials

18

Recruited

580+