Nanoparticle Albumin-Bound Rapamycin and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
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|ClinicalTrials.gov Identifier: NCT03660930|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : February 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Soft Tissue Sarcoma Locally Advanced Soft Tissue Sarcoma Metastatic Soft Tissue Sarcoma||Drug: Nanoparticle Albumin-Bound Rapamycin Drug: Pazopanib hydrochloride||Phase 1 Phase 2|
OUTLINE: This is a phase I, dose-escalation study of nanoparticle albumin-bound rapamycin followed by a phase II study.
Participants receive ABI-009 intravenously (IV) on days 1 and 8 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of ABI-009 (Nab-Rapamycin) With Pazopanib (VOTRIENT®) in Patients With Advanced Nonadipocytic Soft-Tissue Sarcomas|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||February 28, 2025|
Experimental: Treatment (ABI-009, pazopanib)
Participants receive nanoparticle albumin-bound rapamycin IV on days 1 and 8 and pazopanib hydrochloride PO daily on days 1-21. Courses 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.
Drug: Nanoparticle Albumin-Bound Rapamycin
Drug: Pazopanib hydrochloride
Other Name: Votrient
- The maximum-tolerated dose (MTD) of nab-rapamycin in combination with pazopanib (Phase I) [ Time Frame: Up to 21 days ]Will be estimated using dose-limiting toxicities (DLTs). Will use a Simon's minimax design.
- Progression-free survival (PFS) rate (Phase II) [ Time Frame: At 3 months ]Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Will be assessed via descriptive statistics.
- Incidence of adverse events profile (Phase I and II) [ Time Frame: Up to 28 days after last dose ]Will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Median overall survival (OS) (Phase II) [ Time Frame: At 12 months ]Will be summarized using Kaplan-Meier (KM) analysis and descriptive statistics.
- Median PFS (Phase II) [ Time Frame: At 6 months ]Will be summarized using KM analysis and descriptive statistics.
- Disease control rate (complete response [CR] +partial response [PR] + stable disease [SD]) (Phase II) [ Time Frame: Up to 2 years ]Will be based on RECIST v1.1. Will be evaluated by computed tomography (CT) imaging.
- Duration of response (Phase II) [ Time Frame: Up to 2 years ]Will be evaluated by CT imaging.
- Objective response rate (CR + PR) (Phase II) [ Time Frame: Up to 2 years ]Will be based on RECIST v1.1. Will be evaluated by CT imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660930
|Contact: Roxanne Moorefirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Roxanne Moore 206-606-6425 email@example.com|
|Principal Investigator: Lee Cranmer, MD|
|Principal Investigator:||Lee Cranmer, MD||Fred Hutch/University of Washington Cancer Consortium|