NCT03735446

Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial

Prexasertib in Combination With Mitoxantrone, Etoposide and Cytarabine (MEC) in Relapsed/Refractory Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) - a Phase I Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy combined with chemotherapy as a possible treatment for acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS). The drugs involved in this study are: * Prexasertib (LY2606368) * Mitoxantrone * Etoposide * Cytarabine

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved prexasertib as a treatment for any disease. Prexasertib is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer. CHK1 inhibitors work by preventing cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death. The drugs mitoxantrone, etoposide, and cytarabine (MEC) have all been approved by the FDA. MEC is a standard chemotherapy treatment option, commonly used for AML that has not responded to other standard treatment or returned following standard treatment. In this research study, the investigators are combining prexasertib with MEC therapy to test if it is a safe treatment for AML or MDS that has returned or not responded to standard treatment.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Prexasertib	Checkpoint kinase 1 (CHK1) inhibitor
DRUG	Mitoxantrone	Standard chemotherapy (topoisomerase inhibitor)
DRUG	Etoposide	Standard chemotherapy (topoisomerase II inhibitor)
DRUG	Cytarabine	Standard chemotherapy (anti-metabolite)

Timeline

• Start date: 2019-01-18
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2018-11-08
• Last updated: 2019-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study