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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Progression-free Survival (PFS) Rate (Phase II)
+2 moreSecondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,332 Total Patients Enrolled
Aadi Bioscience, Inc.Industry Sponsor
16 Previous Clinical Trials
522 Total Patients Enrolled
Lee Cranmer, MDPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been treated with drugs that target blood vessel growth or cell growth.I have not had a heart attack or any major heart issues in the last 6 months.I have an active hepatitis B or C infection.I am fully active or restricted in physically strenuous activity but can do light work.I finished treatment for an infection less than 14 days ago, except for a simple UTI or cold.I haven't taken strong medication that affects liver enzymes in the last 14 days.I haven't had any intestinal issues or severe bleeding in the last 6 months.I have a history of lung disease or high blood pressure in the lungs.I have not had major surgery or open wounds with complications in the last 28 days.My blood pressure is not controlled, even with treatment.My kidney function, measured by creatinine levels, is within the normal range.I am using or agree to use effective birth control and will take pregnancy tests as required.I will not have unprotected sex with a woman who can become pregnant or is pregnant while in the study.I have a tumor that can be measured by CT scan or MRI.I am 18 or older with a specific type of advanced cancer not treatable by surgery, and I need a specific medication.My advanced disease worsened or I couldn't tolerate at least 1 treatment, but I've had no more than 4 treatments.I do not have an active cancer except for certain treated or non-serious types.I do not have severe liver problems or active bleeding in my stomach or intestines.I haven't had any bleeding issues like coughing up blood or bleeding in the brain or stomach in the last 6 months.I am HIV positive or have AIDS.I am being treated with simvastatin for high cholesterol.My sarcoma is not treatable with pazopanib due to its specific type.I do not have any serious uncontrolled medical or mental health conditions.I finished my last cancer treatment at least 14 days ago and have no severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ABI-009, pazopanib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what circumstances is Nanoparticle Albumin-Bound Rapamycin traditionally administered?
"Nanoparticle Albumin-Bound Rapamycin has demonstrated effectiveness in providing a prophylactic solution for hypovolemia as well as treating organ transplantation, liver failure, and acute forms of the ailment."
Answered by AI
What primary goal does this experiment seek to accomplish?
"The major objective of this study, examined within a 21-day window, is to calculate the Progression-free survival (PFS) rate. Secondary endpoints are focused on calculating Duration of response through CT imaging; Median PFS with Kaplan Meier analysis and descriptive statistics; and Median overall survival also employing KM analysis and descriptors."
Answered by AI
What is the aggregate figure of participants enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov details that this medical trial, which debuted on April 1st 2019, is actively recruiting volunteers. 57 participants are required to be sourced from one site location."
Answered by AI
Are there still vacancies for participants in this medical trial?
"Correct. Per the records on clinicaltrials.gov, this medical experiment is presently looking for participants and was first posted on April 1st 2019 with a most recent update made to August 16th 2022. 57 subjects need to be recruited from only 1 site."
Answered by AI
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