Clinical trials: Decitabine, completed
Sickle Cell Disease
Research Study Investigating How Well NDec Works in People With Sickle Cell Disease
This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine).
- Trial name
- ASCENT1 (NCT05405114)
- Testing
- NDec - oral decitabine-tetrahydrouridine, HU - Hydroxyurea
- Where
- 118 sites in United States, Canada and 12 more
- Volunteers
- 96 people
- Sponsor
- Novo Nordisk A/S
AML, Adult Recurrent, MDS
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk…
- Trial name
- NCT05829226
- Testing
- LYT-200, Venetoclax, Azacitidine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- PureTech
Myelodysplastic Syndromes
Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category…
- Trial name
- NCT03502668
- Testing
- ASTX727 LD, ASTX727 SD
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 160 people
- Sponsor
- Taiho Oncology, Inc.
Healthy Volunteers
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People
This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine).
- Trial name
- NCT06291285
- Testing
- Decitabine-THU
- Where
- 2 sites in United States, Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males
This is an open-label, randomized, single-dose per period, two-period, crossover study to evaluate the relative bioavailability of decitabine and tetrahydrouridine ingested as a modified-release combination formulation compared…
- Trial name
- NCT05816356
- Testing
- Decitabine, Tetrahydrouridine
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- EpiDestiny, Inc.
Leukemia, Leukemia, Myeloid
Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- Trial name
- NCT03066648
- Testing
- Decitabine, PDR001, MBG453
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC)
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1…
- Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- Trial name
- NCT02649790
- Testing
- KPT-8602, ASTX727, Dexamethasone
- Where
- 46 sites in United States, Canada and 3 more
- Volunteers
- 277 people
- Sponsor
- Karyopharm Therapeutics Inc
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS
A Phase Ib/II multicentre open label study of bemcentinib (BGB324) as a single agent in participants with Acute Myeloid Leukemia (AML) or Myelodysplastic syndrome (MDS) or in a combination with cytarabine or decitabine in AML…
- Trial name
- NCT02488408
- Testing
- Bemcentinib, Cytarabine, Decitabine
- Where
- 12 sites in United States, Germany and 2 more
- Volunteers
- 122 people
- Sponsor
- BerGenBio ASA
Myelodysplastic Syndrome, MDS
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
- Trial name
- NCT02103478
- Testing
- ASTX727 Dose Escalation, ASTX727 Dose Confirmation, ASTX727 Fixed-Dose Combination
- Where
- 17 sites in United States, Canada
- Volunteers
- 130 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML
Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2…
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03306264
- Testing
- ASTX727, Dacogen
- Where
- 84 sites in United States, Austria and 8 more
- Volunteers
- 227 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Chronic Myelogenous Leukemia
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became…
- Trial name
- NCT00042003
- Testing
- decitabine (5-aza-2'deoxycytidine)
- Where
- 8 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Myelodysplastic Syndrome
Decitabine Versus Supportive Care in Adults With Advanced-stage MDS
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
- Trial name
- NCT00043381
- Testing
- decitabine (5-aza-2'deoxycytidine)
- Where
- 24 sites in United States
- Volunteers
- 160 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Effect of Food on Blood Levels of ASTX727
This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants…
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03813186
- Testing
- ASTX727 + Day 2 Food, ASTX727 + Day 4 Food
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Leukemia, Myeloid, Acute
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension.
- Trial name
- NCT02632721
- Testing
- Decitabine, BI 836858
- Where
- 14 sites in United States, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndrome
Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)
The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.
- Trial name
- NCT00941109
- Testing
- decitabine
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eisai Inc.
Acute Myeloid Leukemia (AML), Cancer
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
- Trial name
- NCT03941964
- Testing
- Venetoclax, Azacitidine, Decitabine
- Where
- 16 sites in United States
- Volunteers
- 60 people
- Sponsor
- AbbVie
Acute Myeloid Leukemia
Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)
The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or…
- Trial name
- NCT03303339
- Testing
- Onvansertib, Cytarabine, Decitabine
- Where
- 9 sites in United States
- Volunteers
- 72 people
- Sponsor
- Cardiff Oncology
Acute Myeloid Leukemia
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard…
- Trial name
- SEAMLESS (NCT01303796)
- Testing
- Sapacitabine, Decitabine
- Where
- 118 sites in United States, Austria and 10 more
- Volunteers
- 482 people
- Sponsor
- Cyclacel Pharmaceuticals, Inc.
Acute Myeloid Leukemia
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
- Trial name
- NCT01546038
- Testing
- PF-04449913, Low dose ARA-C (LDAC), Decitabine
- Where
- 81 sites in United States, Canada and 4 more
- Volunteers
- 255 people
- Sponsor
- Pfizer
Healthy
Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects
This study is to investigate the effect of a high fat meal on the pharmacokinetics of decitabine and THU in healthy adults when administered as a modified release formulation of the 2 drugs in combination.
- Trial name
- NCT04086238
- Testing
- Decitabine
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- EpiDestiny, Inc.