NCT03718143

AZD1775 in Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myelofibrosis

Terminated Phase 2 Results posted Last updated 2 June 2020

What this trial tests

Phase 2 trial testing Combination AZD1775 with AraC in Myelofibroses in 6 participants. Terminated before completion.

Timeline

8 May 2019

Primary endpoint
27 September 2019

27 September 2019

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	8 May 2019
Primary completion	27 September 2019
Estimated completion	27 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Combination AZD1775 with AraC — full drug profile →
• AZD1775 only — full drug profile →

Conditions studied

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

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 99, any sex, with Myelofibroses or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Elderly Newly Diagnosed AML

Serious: 1/3 (33%)

Deaths: 1/3

Arm B:Relapsed AML and MDS

Serious: 0/2 (0%)

Deaths: 0/2

Arm C: Relapsed AML, MDS and MF

Serious: 0/1 (0%)

Deaths: 0/1

Serious adverse events (1 terms)

Reaction	System	Arm A: Elderly Newly Diagn…	Arm B:Relapsed AML and MDS	Arm C: Relapsed AML, MDS a…
Progression of Disease	General disorders	—	—	—

Most-reported serious reactions: Progression of Disease.

Data from ClinicalTrials.gov NCT03718143 adverse events section.

Sponsor's own description

A phase II study testing the efficacy of combined AZD1775 with AraC or single agent activity of AZD1775 in three arms: Arm A has subjects age 60 years or older who are newly diagnosed with AML receiving the combination of the drugs; Arm B has subjects who are have relapsed/refractory AML and HMA failure MDS patients being allocated to either the combination Arm B or single agent AZD1775 Arm C.

Publications & conference data

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

1. A WEE1 family business: regulation of mitosis, cancer progression, and therapeutic target.
   Ghelli Luserna di Rorà A, Cerchione C, Martinelli G, Simonetti G. · · 2020 · cited 232× · PMID 32958072 · DOI 10.1186/s13045-020-00959-2
2. Targeting the DNA damage response for cancer therapy.
   Curtin NJ. · · 2023 · cited 30× · PMID 36606678 · DOI 10.1042/bst20220681
3. 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
4. Synthetic and Medicinal Chemistry Approaches Toward WEE1 Kinase Inhibitors and Its Degraders.
   Alli VJ, Yadav P, Suresh V, Jadav SS. · · 2023 · cited 18× · PMID 37323408 · DOI 10.1021/acsomega.3c01558
5. Targeting the DNA damage response in cancer.
   Federica G, Michela C, Giovanna D. · · 2024 · cited 12× · PMID 39492835 · DOI 10.1002/mco2.788
6. Targeting the DNA damage response in hematological malignancies.
   De Mel S, Lee AR, Tan JHI, Tan RZY, et al · · 2024 · cited 4× · PMID 38347838 · DOI 10.3389/fonc.2024.1307839
7. The interplay of DNA damage, epigenetics and tumour heterogeneity in driving cancer cell fitness.
   Rouault CD, Charafe-Jauffret E, Ginestier C. · · 2025 · cited 3× · PMID 41028732 · DOI 10.1038/s41467-025-64445-4
8. <i>SETD8^C302R</i> Mutation Revealed from Myofibroblastoma-Discordant Monozygotic Twins Leads to p53/p21 Deficit and WEE1 Inhibitor Sensitivity.
   Li M, Wang H, Liao H, Shen J, et al · · 2020 · cited 2× · PMID 33042742 · DOI 10.1002/advs.202001041