FID-007 in Treating Participants With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT03537690 |
Recruitment Status :
Recruiting
First Posted : May 25, 2018
Last Update Posted : March 15, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | May 15, 2018 | ||||||||
First Posted Date ICMJE | May 25, 2018 | ||||||||
Last Update Posted Date | March 15, 2024 | ||||||||
Actual Study Start Date ICMJE | May 25, 2018 | ||||||||
Estimated Primary Completion Date | May 25, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Clinical anti-tumor response (Complete Response [CR] and Partial Response [PR]) [ Time Frame: Up to 2 years ] Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | FID-007 in Treating Participants With Advanced Solid Tumors | ||||||||
Official Title ICMJE | A Phase I Study of FID-007 in Patients With Advanced Solid Tumors | ||||||||
Brief 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. | ||||||||
Detailed Description | PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose (RP2D). II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated with FID-007. SECONDARY OBJECTIVES: I. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.3. II. To obtain a preliminary assessment of anti-tumor activity of FID-007 via objective radiologic tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. EXPLORATORY OBJECTIVES: I. To evaluate in a preliminary fashion the serum concentration of total paclitaxel and free paclitaxel, and explore potential associations with serum concentrations, efficacy and toxicity. OUTLINE: This is a dose escalation study. Participants receive FID-007 intravenously (IV) over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up periodically. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (FID-007)
Participants receive FID-007 IV over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
36 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 25, 2026 | ||||||||
Estimated Primary Completion Date | May 25, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03537690 | ||||||||
Other Study ID Numbers ICMJE | 0C-18-2 NCI-2018-00758 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 0C-18-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | University of Southern California | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | University of Southern California | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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PRS Account | University of Southern California | ||||||||
Verification Date | March 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |