19 Participants Needed

Nab-Sirolimus + Pazopanib for Soft Tissue Sarcoma

RM
Overseen ByRoxanne Moore
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Washington
Must be taking: Pazopanib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Cranmer | Division of Hematology & Oncology

Lee Cranmer

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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.
See 17 more

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.
See 17 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (ABI-009, pazopanib)Experimental Treatment2 Interventions

Find a Clinic Near You

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+
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