Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial
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|ClinicalTrials.gov Identifier: NCT03735446|
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : January 25, 2019
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)
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes||Drug: Prexasertib Drug: Mitoxantrone Drug: Etoposide Drug: Cytarabine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||July 14, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Checkpoint kinase 1 (CHK1) inhibitor
Other Name: LY2606368
Standard chemotherapy (topoisomerase inhibitor)
Other Name: Novantrone
Standard chemotherapy (topoisomerase II inhibitor)
Standard chemotherapy (anti-metabolite)
- Dose Limiting Toxicity [ Time Frame: Up to 42 days ]Toxicities occurring following administration of protocol therapy, measured using CTCAE 5.0 criteria.
- Phase 2 Dose [ Time Frame: 18 months ]Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the study drug combination.
- Overall Response [ Time Frame: 30 months ]Rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR).
- Overall Survival [ Time Frame: 30 months ]Assess the overall survival rate for the combination.
- Duration of Remission [ Time Frame: 12 months ]Time of achievement of CR or CRi to relapse, death, or 1 year (whichever occurs first)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735446
|Contact: Eric S. Winer, MD||617-632-3000||EricS_Winer@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Eric s Winer, MD 617-632-3000 EricS_Winer@DFCI.HARVARD.EDU|
|Principal Investigator: Eric S. Winer, MD|
|Principal Investigator:||Eric S Winer, MD||Dana-Farber Cancer Institute|