Advanced Soft Tissue SarcomaPhase 1/2NCT03660930
Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
A Phase 1/2 study testing Sirolimus Albumin-bound Nanoparticles and Pazopanib hydrochloride in people with Advanced Soft Tissue Sarcoma and Locally Advanced Soft Tissue Sarcoma, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma
- What is being tested?
- Sirolimus Albumin-bound Nanoparticles and Pazopanib hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Jul 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, >= 18 years old, must have a histologically confirmed diagnosis of non-adipocytic soft tissue sarcoma (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.
- Subjects must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, assessed via computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Clinical or radiological progression or failure due to toxicity on at least 1 prior regimen of systemic treatment for advanced disease. Subjects may not have received more than 4 prior lines of systemic therapy (no more than 2 prior therapies may be combination cytotoxic therapies). Neo-adjuvant/adjuvant/maintenance treatments are not included for this criterion.
- Last dose of prior therapy must have been completed a minimum of 14 days prior to start of protocol therapy. All ongoing toxicities related to prior therapy must be resolved or grade 1 (except alopecia).
- NOTE: Toxicities from prior therapy that have resolved with sequelae (e.g. hypothyroidism) and are asymptomatic or well-controlled are not exclusionary.
- Total bilirubin =< upper limit of normal (ULN) mg/dL (Subjects with known Gilbert's syndrome and a total bilirubin =< 3 mg/dl are permitted to enroll to phase 2/expansion phase only with sponsor-investigator approval).
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- Aspartate aminotransferase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x ULN.
- Serum creatinine =<1.5 x ULN (If serum creatinine is > 1.5 mg/dL, calculated creatinine clearance > 50 mL/min using the Cockcroft-Gault formula may be included).
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
- Platelet count >= 100,000/mm^3 (100 x 10^9/L).
- Hemoglobin >= 9 g/dL.
- Serum triglyceride =< 300 mg/dL.
- Serum cholesterol =< 350 mg/dL.
- Baseline cardiac left ventricular ejection fraction (LVEF) within institutional limits of normal (by echocardiogram or multigated acquisition [MUGA] study).
- Baseline electrocardiogram with corrected QT (QTc) < 480 millisecond (Bazett's).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Male or non-pregnant and non-breast feeding female:
- Females of child-bearing potential must agree to use highly effective contraception without interruption from initiation of therapy and while on study medication and have a negative serum pregnancy test (beta human chorionic gonadotropin [beta-hCG]) result at screening and agree to ongoing pregnancy testing during the course of the study, and at the end of study treatment. A highly effective method of contraception is defined as one that results in a low failure rate (that is, < 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner.
- Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.
- Life expectancy of > 3 months, as determined by the investigator.
- Ability to understand and sign informed consent.
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Who cannot join
- Soft tissue sarcomas with biology or defined treatments for which pazopanib is not indicated, including adipocytic STS, gastrointestinal stromal tumors (GIST), or Kaposi's sarcoma.
- Previously received an mTOR (mammalian target of rapamycin) inhibitor or angiogenesis inhibitor.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A subject with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases >= 28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- Subjects with hemoptysis, central nervous system hemorrhage or gastrointestinal hemorrhage within the last 6 months prior to treatment are excluded due to pazopanib-associated risk of bleeding.
- Subjects with severe hepatic impairment and active gastrointestinal bleeding.
- Uncontrolled serious medical or psychiatric illness.
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- Subjects with a currently active second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, or other adequately treated carcinoma-in-situ are ineligible. Subjects are not considered to have a currently active malignancy if they have completed therapy and are free of disease for >= 1 year).
- Recent infection requiring systemic anti-infective treatment that was completed =< 14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
- 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.
- Subjects with unstable coronary artery disease, myocardial infarction, or an arterial thromboembolic event during preceding 6 months.
- Subjects with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of nab-sirolimus. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfenadine) within the 14 days prior to receiving the first dose of nab-sirolimus.
- Active hepatitis B or hepatitis C infection.
- Systemic immunosuppression, including human immunodeficiency virus (HIV) positive status with or without acquired immunodeficiency syndrome (AIDS).
- Subjects with history of intestinal perforations, fistula, hemorrhages and/or hemoptysis =< 6 months prior to first study treatment.
- Subjects with hypercholesterolemia receiving ongoing treatment with simvastatin.
- Subjects who have had major surgery within 28 days of planned initiation of protocol therapy, or patients who have/have had wound dehiscence, or other open wounds (including diabetic or infectious wounds) with active wound complications.
- Subjects with prior history of severe hypersensitivity (grade 3 or higher) to any known drug excipients, including anaphylaxis to human serum albumin.
- Subjects with uncontrolled hypertension, defined as an average systolic blood pressure (SBP) >= 140 mmHg or an average diastolic blood pressure (DBP) >= 90 mmHg despite best supportive care measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase 1/2 Study of Nab-Sirolimus With Pazopanib (VOTRIENT®) in Patients With Advanced Nonadipocytic Soft-Tissue Sarcomas
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.
Read the 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
- Being tested
- Sirolimus Albumin-bound Nanoparticles, Pazopanib hydrochloride
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Albumin-bound NanoparticlesDrug
Also called Nab-Rapamycin, Nanoparticle Albumin-Bound Rapamycin, ABI-009, Nanoparticle Albumin-bound Sirolimus
Given IV
Pazopanib hydrochlorideDrug
Also called Votrient
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ABI-009, pazopanib) | Experimental | 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. Receives: Drug: Sirolimus Albumin-bound Nanoparticles; Drug: Pazopanib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Measured: First 2 cycles (3-week cycles, 21 days each)
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Measured: First 2 cycles (3-week cycles, 21 days each)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-sirolimus and pazopanib. Only toxicities with a clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic AE of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Measured: First 2 cycles (3-week cycles, 21 days each)
Dose Limiting Toxicities
A Dose-limiting toxicity is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-Sirolimus or pazopanib. Only toxicities with clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic Ae of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Measured: First 2 cycles (3 week cycles, 21 days each)
Progression-free Survival (PFS) Rate
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 where progression is defined as a 20% increase in the sum of the longest diameter of target lesions where the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions. Will be assessed via descriptive statistics.
Measured: At 3 months
Secondary outcomes (8)
Incidence of Adverse Events Profile
Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either nab-sirolimus therapy, pazopanib therapy, or both.
Measured: Up to 30 days after last dose (an average of 41 weeks)
Median PFS
Will be assessed using RECIST v1.1. Will be assessed via descriptive statistics.
Measured: At 6 months
Progression-Free Survival Rate
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Will be assessed via descriptive statistics.
Measured: At 6 months
Median Overall Survival (OS)
Will be summarized using descriptive statistics.
Measured: At 12 months
Overall Survival
Will be assessed using descriptive statistics.
Measured: 12 months
Objective Response Rate (CR + PR)
Will be based on RECIST v1.1. Will be evaluated by CT imaging.
Measured: Up to 2 years
Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD])
Will be based on RECIST v1.1evaluated by computed tomography (CT) imaging. Per RECIST V1.1, Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Measured: at 24 weeks
Duration of Response
Will be evaluated by CT imaging.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Apr 2019
- Primary completion17 Nov 2022
- Study completion31 Jul 2024
Why it stopped: Study was terminated at completion of the Phase 1 dose escalation due to loss of financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Aadi Bioscience, Inc.
- Responsible party
- Principal investigator, Lee Duncan Cranmer, University of Washington
- Investigators
- Lee Cranmer, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660930
- Sponsor's protocol ID
- RG1718053
- Other IDs
- 10015, NCI-2018-01624
- Status last verified
- Apr 2025
- First submitted
- 4 Sep 2018
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Nab-Sirolimus With Pazopanib (VOTRIENT®) in Patients With Advanced Nonadipocytic Soft-Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT03660930
- Acronym / sponsor ID
- RG1718053
- Conditions
- Advanced Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated at completion of the Phase 1 dose escalation due to loss of financial support.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Aadi Bioscience, Inc.
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ABI-009, pazopanib) | Experimental | Drug: Sirolimus Albumin-bound Nanoparticles, Drug: Pazopanib hydrochlorideParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subjects, >= 18 years old, must have a histologically confirmed diagnosis of non-adipocytic soft tissue sarcoma (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.
- Subjects must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, assessed via computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Clinical or radiological progression or failure due to toxicity on at least 1 prior regimen of systemic treatment for advanced disease. Subjects may not have received more than 4 prior lines of systemic therapy (no more than 2 prior therapies may be combination cytotoxic therapies). Neo-adjuvant/adjuvant/maintenance treatments are not included for this criterion.
- Last dose of prior therapy must have been completed a minimum of 14 days prior to start of protocol therapy. All ongoing toxicities related to prior therapy must be resolved or grade 1 (except alopecia).
- Total bilirubin =< upper limit of normal (ULN) mg/dL (Subjects with known Gilbert's syndrome and a total bilirubin =< 3 mg/dl are permitted to enroll to phase 2/expansion phase only with sponsor-investigator approval).
Key exclusion criteria (20 listed)
- Soft tissue sarcomas with biology or defined treatments for which pazopanib is not indicated, including adipocytic STS, gastrointestinal stromal tumors (GIST), or Kaposi's sarcoma.
- Previously received an mTOR (mammalian target of rapamycin) inhibitor or angiogenesis inhibitor.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A subject with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases >= 28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- Subjects with hemoptysis, central nervous system hemorrhage or gastrointestinal hemorrhage within the last 6 months prior to treatment are excluded due to pazopanib-associated risk of bleeding.
- Subjects with severe hepatic impairment and active gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus Albumin-bound NanoparticlesAlso: Nab-Rapamycin, Nanoparticle Albumin-Bound Rapamycin, ABI-009, Nanoparticle Albumin-bound SirolimusGiven IV | Drug | Treatment (ABI-009, pazopanib) |
| Pazopanib hydrochlorideAlso: VotrientGiven PO | Drug | Treatment (ABI-009, pazopanib) |
Primary outcome
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose
Time frame: First 2 cycles (3-week cycles, 21 days each)
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Pazopanib Dose
Time frame: First 2 cycles (3-week cycles, 21 days each)
Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: First 2 cycles (3-week cycles, 21 days each)
A DLT is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-sirolimus and pazopanib. Only toxicities with a clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic AE of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Dose Limiting Toxicities
Time frame: First 2 cycles (3 week cycles, 21 days each)
A Dose-limiting toxicity is defined as any Grade 3 or greater adverse event (AE), at least possibly related to either or both nab-Sirolimus or pazopanib. Only toxicities with clearly identified and documented alternative explanation may be deemed non-DLT. Dose-limiting toxicities include any death not clearly due to underlying disease or extraneous causes, or persistent intolerable nonhematologic Ae of any grade that requires dose reduction or permanent discontinuation of the study drug, in the opinion of the investigator.
Progression-free Survival (PFS) Rate
Time frame: At 3 months
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 where progression is defined as a 20% increase in the sum of the longest diameter of target lesions where the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of new lesions. Will be assessed via descriptive statistics.
8 secondary outcomes
Incidence of Adverse Events Profile
Time frame: Up to 30 days after last dose (an average of 41 weeks)
Median PFS
Time frame: At 6 months
Progression-Free Survival Rate
Time frame: At 6 months
Median Overall Survival (OS)
Time frame: At 12 months
Overall Survival
Time frame: 12 months
Objective Response Rate (CR + PR)
Time frame: Up to 2 years
Disease Control Rate (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD])
Time frame: at 24 weeks
Duration of Response
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Cranmer, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sirolimus Albumin-bound Nanoparticles and Pazopanib hydrochloride in people with Advanced Soft Tissue Sarcoma and Locally Advanced Soft Tissue Sarcoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum-tolerated Dose (MTD) of Nab-rapamycin in Combination With Pazopanib (Phase I) - Nab-Rapamycin Dose (time frame: First 2 cycles (3-week cycles, 21 days each)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.