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DRUG CLASS:

Cytidine deaminase inhibitor

18h
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors (clinicaltrials.gov)
P1, N=18, Recruiting, Pamela Munster | Trial completion date: Feb 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2028
Trial completion date • Trial primary completion date
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2)
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PALB2 mutation • CHEK2 mutation
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Lynparza (olaparib) • Inqovi (decitabine/cedazuridine)
2d
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes (clinicaltrials.gov)
P1/2, N=72, Active, not recruiting, Otsuka Beijing Research Institute | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Dec 2025 --> May 2026
Trial completion date • Trial primary completion date
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Inqovi (decitabine/cedazuridine)
7d
A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=47, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027 | Initiation date: Oct 2025 --> Apr 2026 | Trial primary completion date: Jan 2026 --> Jan 2027
Trial completion date • Trial initiation date • Trial primary completion date
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CD4 (CD4 Molecule)
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Inqovi (decitabine/cedazuridine) • Neupogen (filgrastim)
21d
Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors (clinicaltrials.gov)
P1, N=35, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Jul 2027 | Trial primary completion date: Jan 2026 --> Sep 2026
Enrollment closed • Trial completion date • Trial primary completion date
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decitabine • Inqovi (decitabine/cedazuridine)
22d
NCI-2021-06095: ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
P1/2, N=42, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2026 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2028
Trial completion date • Trial primary completion date
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FLT3 (Fms-related tyrosine kinase 3)
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FLT3-ITD mutation • FLT3 mutation
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Venclexta (venetoclax) • Xospata (gilteritinib) • Inqovi (decitabine/cedazuridine)
1m
ASCENT1: Research Study Investigating How Well NDec Works in People With Sickle Cell Disease (clinicaltrials.gov)
P2, N=96, Completed, Novo Nordisk A/S | Trial primary completion date: Dec 2024 --> Jul 2025
Trial primary completion date
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hydroxyurea • decitabine/ tetrahydrouridine (EPI01)
1m
Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma (clinicaltrials.gov)
P2, N=9, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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BAP1 (BRCA1 Associated Protein 1)
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Inqovi (decitabine/cedazuridine)
1m
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas (clinicaltrials.gov)
P1, N=18, Recruiting, Massachusetts General Hospital | Trial completion date: May 2025 --> Aug 2028 | Trial primary completion date: May 2024 --> Jan 2027
Trial completion date • Trial primary completion date
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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IDH2 mutation
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Inqovi (decitabine/cedazuridine)
2ms
Enrollment closed
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Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
2ms
Trial initiation date
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Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Rezlidhia (olutasidenib)
2ms
Trial suspension
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Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Actimab-A (lintuzumab-Ac225)
2ms
ASCERTAIN-V: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1/2, N=101, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Dec 2025 --> Dec 2026
Trial completion date
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Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)