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Phase I Study of CPI-300 in Patients With Advanced Tumors
NCT04808453 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).
Conditions Studied
Interventions
- DRUG CPI-300
Study Locations (4)
Arizona
- Honor Health Research Institute — Scottsdale
Florida
- Florida Cancer Specialists — Lake Mary
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
Tennessee
- Sarah Cannon Research Institute — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-06-15 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04808453
The ClinicalTrials.gov registry entry for NCT04808453 describes a study currently listed as completed. 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 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coordination Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Tumors appearing as the primary indexed condition, and to 1 intervention — of which CPI-300 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: NCT04808453 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Florida, Ohio. 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 NCT04808453 about?
NCT04808453 is a clinical study titled "Phase I Study of CPI-300 in Patients With Advanced Tumors". This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).
What is the current status of trial NCT04808453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-06-15. Estimated completion is 2023-12-15.
What conditions does trial NCT04808453 study?
This clinical trial studies the following conditions: Advanced Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04808453?
The interventions under investigation include: CPI-300 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04808453?
This trial is sponsored by Coordination Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04808453 being conducted?
This trial has 4 study locations across Arizona, Florida, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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