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NCT04006847 · ClinicalTrials.gov registry record · Phase 1
Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
A Phase 1 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04006847 is a Phase 1 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT04006847, a Phase 1 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a Phase I/II single site, open label clinical trial. The purpose of the Phase I portion is to determine the safety, tolerability, and recommended Phase II dose of Eicosapentaenoic Acid (EPA) when given daily in combination with a Tyrosine Kinase Inhibitor (TKI) in subjects with Chronic Myeloid Leukemia (CML) in chronic stable phase. The recommended Phase II dose will be the maximum tolerated dose (MTD) of EPA as determined by the evaluation of dose-limiting toxicities (DLTs). The Phase II portion will subsequently examine the Anti-CML effects of EPA when administered with a TKI at the recommended Phase II dose. This efficacy objective will be done by evaluating BCR-ABL p210 quantitative PCR blood levels every 3 months to 1 year.
Interventions
- DRUG Eicosapentaenoic Acid
- DRUG Tyrosine kinase inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2021-05-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04006847
The ClinicalTrials.gov registry entry for NCT04006847 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Eicosapentaenoic Acid is the first listed.
NCT04006847 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04006847 about?
NCT04006847 is a clinical study titled "Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia". This is a Phase I/II single site, open label clinical trial. The purpose of the Phase I portion is to determine the safety, tolerability, and recommended Phase II dose of Eicosapentaenoic Acid (EPA) when given daily in combination with a Tyrosine Kinase Inhibitor (TKI) in subjects with Chronic Myelo...
What is the current status of trial NCT04006847?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-09-14. Estimated completion is 2021-05-21.
What interventions are being tested in trial NCT04006847?
The interventions under investigation include: Eicosapentaenoic Acid (DRUG), Tyrosine kinase inhibitor (DRUG).
Who is sponsoring clinical trial NCT04006847?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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