drugset / Trial / NCT04006847
Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-09-14
- Primary completion
- 2021-05-21
- Completion
- 2021-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eicosapentaenoic acid | Small molecule | 500 mg | Oral |
| Subject | Eicosapentaenoic acid | Small molecule | 1000 mg | Oral |
| Subject | Eicosapentaenoic acid | Small molecule | 1500 mg | Oral |
| Subject | Eicosapentaenoic acid | Small molecule | 2000 mg | Oral |
| Subject | Eicosapentaenoic acid | Small molecule | 3000 mg | Oral |
| Background | Bosutinib | Small molecule | — | — |
| Background | Imatinib | Small molecule | — | — |
| Background | Nilotinib | Small molecule | — | — |
| Background | dasatinib anhydrous | Small molecule | — | — |