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A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma
NCT04047251 · View on ClinicalTrials.gov ↗
Study Summary
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended Phase 2 dose (RP2D) of FF-10850 (topotecan liposome injection) in patients with advanced solid tumors including Merkel Cell Carcinoma
Conditions Studied
Interventions
- DRUG FF-10850 Topotecan Liposome Injection
Study Locations (7)
Arizona
- HonorHealth — Scottsdale
Colorado
- Sarah Cannon Research Institute at HealthONE — Denver
Massachusetts
- Dana Farber Cancer Institute (DFCI) — Boston
New York
- Icahn School of Medicine at Mount Sinai — New York
Ohio
- Ohio State University Wexner Medical Center — Columbus
Texas
- MD Anderson Cancer Center — Houston
Wisconsin
- University of Wisconsin Clinical Science Center — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-11-14 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04047251
The ClinicalTrials.gov registry entry for NCT04047251 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fujifilm Pharmaceuticals U.S.A., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which FF-10850 Topotecan Liposome Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04047251 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Arizona, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04047251 about?
NCT04047251 is a clinical study titled "A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma". To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended Phase 2 dose (RP2D) of FF-10850 (topotecan liposome injection) in patients with advanced solid tumors including Merkel Cell Carcinoma
What is the current status of trial NCT04047251?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2019-11-14. Estimated completion is 2026-07.
What conditions does trial NCT04047251 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Merkel Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04047251?
The interventions under investigation include: FF-10850 Topotecan Liposome Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04047251?
This trial is sponsored by Fujifilm Pharmaceuticals U.S.A., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04047251 being conducted?
This trial has 7 study locations across Arizona, Colorado, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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