FID-007 in Treating Participants With Advanced Solid Tumors
NCT03537690 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-29
Summary
This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) in treating participants with malignant neoplasms that have spread to other places in the body and do not respond to treatment. FID-007 is a packaged form of the chemotherapy drug paclitaxel, and uses a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller.
Conditions
- Advanced Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
PEOX-based Polymer Encapsulated Paclitaxel FID-007
Given IV
- OTHER
-
Pharmacokinetic Study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Southern California
lead OTHER
Principal Investigators
-
Anthony El-Khoueiry, MD · University of Southern California
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-25
- Primary Completion
- 2026-12-31
- Completion
- 2027-05-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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