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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: Clinical Trial Phase 1 study, sponsored by Milton S. Hershey Medical Center.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Recommended Phase II dose of EPA will be established by using a standard 3 + 3 statistical design to determine the MTD as assessed by DLTs when administered orally in combination with a TKI in subjects with CML in stable chronic phase. Toxicity will be evaluated using the NCI Common Toxicity Criteria (CTC) version 5.0.
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 |
Why NCT04006847 stopped before completion
NCT04006847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Eicosapentaenoic Acid is the first listed.
NCT04006847 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04006847's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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