NCT03735446 is a Phase 1 clinical trial of Prexasertib in Acute Myeloid Leukemia, sponsored by Dana-Farber Cancer Institute.

Who is sponsoring NCT03735446?

NCT03735446 is sponsored by Dana-Farber Cancer Institute.

What drugs are being tested in NCT03735446?

Interventions in NCT03735446: Prexasertib, Mitoxantrone, Etoposide, Cytarabine.

What condition does NCT03735446 study?

NCT03735446 studies Acute Myeloid Leukemia, Myelodysplastic Syndromes.

Is NCT03735446 still recruiting?

NCT03735446 is currently terminated. Last updated 12 June 2019.

Last reviewed 2019-06-12 · How we verify

NCT03735446

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 12 June 2019

What this trial tests

Phase 1 trial testing Prexasertib in Acute Myeloid Leukemia in 2 participants. Terminated before completion.

Timeline

18 January 2019

Primary endpoint
29 March 2019

29 March 2019

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	18 January 2019
Primary completion	29 March 2019
Estimated completion	29 March 2019
Sites	1 location across United States

Drugs / interventions tested

Prexasertib
Mitoxantrone (MITOXANTRONE) — full drug profile →
Etoposide (etoposide) — full drug profile →
Cytarabine — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Dana-Farber Cancer Institute

Who can join

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

Sponsor's own description

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

Publications & conference data

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

Exploiting DNA repair defects in colorectal cancer.
Reilly NM, Novara L, Di Nicolantonio F, Bardelli A. · · 2019 · cited 96× · PMID 30714316 · DOI 10.1002/1878-0261.12467
Novel therapy in Acute myeloid leukemia (AML): moving toward targeted approaches.
Winer ES, Stone RM. · · 2019 · cited 92× · PMID 31321011 · DOI 10.1177/2040620719860645
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
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
Inhibition of Chk2 promotes neuroprotection, axon regeneration, and functional recovery after CNS injury.
Taylor MJ, Thompson AM, Alhajlah S, Tuxworth RI, et al · · 2022 · cited 17× · PMID 36103534 · DOI 10.1126/sciadv.abq2611
Targeting the DNA damage response in cancer.
Federica G, Michela C, Giovanna D. · · 2024 · cited 12× · PMID 39492835 · DOI 10.1002/mco2.788
Cancer Vulnerabilities Through Targeting the ATR/Chk1 and ATM/Chk2 Axes in the Context of DNA Damage.
Fernandez A, Artola M, Leon S, Otegui N, et al · · 2025 · cited 9× · PMID 40422251 · DOI 10.3390/cells14100748
Progress in deciphering the role of p53 in diffuse large B-cell lymphoma: mechanisms and therapeutic targets.
Wen W, Zhang WL, Tan R, Zhong TT, et al · · 2024 · cited 7× · PMID 39113862 · DOI 10.62347/lhio8294

Verify or expand the search:

Other trials of Prexasertib

Trials testing the same drug.

NCT04095221 — A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rh · Phase 1, PHASE2 · completed
NCT04023669 — Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Re · Phase 1 · completed
NCT03495323 — A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumo · Phase 1 · completed
NCT03414047 — A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer · Phase 2 · completed
NCT03057145 — Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors · Phase 1 · completed

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Dana-Farber Cancer Institute trials

Trials by the same sponsor.

NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention · NA · not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo · Phase 2 · not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03735446 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 12 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03735446.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing