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Tyrosine Kinase Inhibitor

Nab-Sirolimus + Pazopanib for Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Led By Lee Cranmer, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Subjects, >= 18 years old, must have a histologically confirmed diagnosis of non-adipocytic STS that is either metastatic or locally advanced and for which curative therapy is not available, surgery is not a recommended option, and pazopanib treatment is indicated.

Must not have

No clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.

Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HbA1c) > 8% despite adequate therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the side effects and best dose of a combination of two drugs to treat advanced sarcomas.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include issues related to liver function, blood pressure changes, increased risk of infections due to immune system suppression, gastrointestinal complications like ulcers or bleeding risks associated with pazopanib hydrochloride.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 or older with a specific type of advanced cancer not treatable by surgery, and I need a specific medication.

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I will not have unprotected sex with a woman who can become pregnant or is pregnant while in the study.

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I finished my last cancer treatment at least 14 days ago and have no severe side effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have been treated with drugs that target blood vessel growth or cell growth.

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I have not had a heart attack or any major heart issues in the last 6 months.

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I have an active hepatitis B or C infection.

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I haven't taken strong medication that affects liver enzymes in the last 14 days.

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I have a history of lung disease or high blood pressure in the lungs.

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I have not had major surgery or open wounds with complications in the last 28 days.

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My blood pressure is not controlled, even with treatment.

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I do not have severe liver problems or active bleeding in my stomach or intestines.

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I haven't had any bleeding issues like coughing up blood or bleeding in the brain or stomach in the last 6 months.

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I am HIV positive or have AIDS.

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I am being treated with simvastatin for high cholesterol.

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My sarcoma is not treatable with pazopanib due to its specific type.

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I do not have any serious uncontrolled medical or mental health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicities

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Progression-free Survival (PFS) Rate (Phase II)

+2 more

Secondary study objectives

Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]) (Phase II)

Duration of Response (Phase II)

Incidence of Adverse Events Profile (Phase I and II)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ABI-009, pazopanib)Experimental Treatment2 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.

0 / 19Eligibility criteria met