NCT02649764

Prexasertib (LY2606368), Cytarabine, and Fludarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed Phase 1 Last updated 4 October 2023

What this trial tests

Phase 1 trial testing Cytarabine in Chronic Myelomonocytic Leukemia in 15 participants. Completed in 12 July 2022.

Timeline

4 May 2016

Primary endpoint
12 July 2022

12 July 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	4 May 2016
Primary completion	12 July 2022
Estimated completion	12 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Cytarabine — full drug profile →
• Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Prexasertib

Conditions studied

• Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
• Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
• Recurrent High Risk Myelodysplastic Syndrome — all drugs for Recurrent High Risk Myelodysplastic Syndrome →
• Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Chronic Myelomonocytic Leukemia or Recurrent Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and determine the best dose of prexasertib (LY2606368) when given together with cytarabine and fludarabine in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement or no longer responds to treatment. Prexasertib (LY2606368) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving prexasertib (LY2606368) together with cytarabine and fludarabine may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ATR/CHK1 inhibitors and cancer therapy.
   Qiu Z, Oleinick NL, Zhang J. · · 2018 · cited 282× · PMID 29054375 · DOI 10.1016/j.radonc.2017.09.043
2. Targeting the ATR-CHK1 Axis in Cancer Therapy.
   Rundle S, Bradbury A, Drew Y, Curtin NJ. · · 2017 · cited 173× · PMID 28448462 · DOI 10.3390/cancers9050041
3. Targeting multiple signaling pathways: the new approach to acute myeloid leukemia therapy.
   Carter JL, Hege K, Yang J, Kalpage HA, et al · · 2020 · cited 148× · PMID 33335095 · DOI 10.1038/s41392-020-00361-x
4. Dysregulated haematopoietic stem cell behaviour in myeloid leukaemogenesis.
   Yamashita M, Dellorusso PV, Olson OC, Passegué E. · · 2020 · cited 128× · PMID 32415283 · DOI 10.1038/s41568-020-0260-3
5. Targeting the DNA Damage Response in OSCC with TP53 Mutations.
   Lindemann A, Takahashi H, Patel AA, Osman AA, et al · · 2018 · cited 117× · PMID 29489434 · DOI 10.1177/0022034518759068
6. Novel therapy in Acute myeloid leukemia (AML): moving toward targeted approaches.
   Winer ES, Stone RM. · · 2019 · cited 92× · PMID 31321011 · DOI 10.1177/2040620719860645
7. Key Proteins of Replication Stress Response and Cell Cycle Control as Cancer Therapy Targets.
   Khamidullina AI, Abramenko YE, Bruter AV, Tatarskiy VV. · · 2024 · cited 34× · PMID 38279263 · DOI 10.3390/ijms25021263
8. Harnessing DNA Replication Stress for Novel Cancer Therapy.
   Zhu H, Swami U, Preet R, Zhang J. · · 2020 · cited 30× · PMID 32854236 · DOI 10.3390/genes11090990