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A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

StatusEnrolling by Invitation
PhasePhase 2
Started2019-09-30
View on ClinicalTrials.gov ↗

Amendment history

2026-07-27
Study Status, Contacts/Locations v31
Study sites48→47
2025-10-30
3 amendments v28-v30
3 re-verifications since 2025-06-30, no change to tracked fields
2025-04-30
Study Status, Contacts/Locations v27
Study sites45→48
2025-03-06
Study Status v26
Primary completion date2025-12-31→2027-12-31
Completion date2025-12-31→2027-12-31
2025-01-31
Study Status, Contacts/Locations v25
Study sites41→45
Show 24 earlier versions
2025-01-07
Study Status, Contacts/Locations v24
Study sites34→41
2024-11-29
Study Status v23
Primary completion date2025-01-31→2025-12-31
Completion date2025-01-31→2025-12-31
2024-10-01
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v22
Primary completion date2024-12-31→2025-01-31
Completion date2024-12-31→2025-01-31
Eligibility criteria+331 characters
[...] the following inclusion criteria: Previous participation in ana Taiho (formerly Astex)-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04, , ASTX727-17, and ASTX727-18, and the food effect substudy of ASTX727-06) in which the participant was treated with ASTX727 and was [...] th ASTX727 at the time of study completion as determined by AstexTaiho. Participant is considered to be benefitting from ASTX727 t [...] ing. Women of childbearing potential must agree to practice 21 highly effective contraceptive methods of birth control during the study and [...] [...]
Secondary endpoints5 to 2 entries
Main Extension Study: Overall Survival: Time to Death from Any Cause Main Extension Study: Percentage of Participants with Haematological Malignancies Undergoing Conversion to AML Main Extension Study: Number of Participants with Solid Tumors with Disease Status: Complete Response (CR), Partial Resp [...]
Study description-16 characters
[...] e parent study protocol. Food Effect Substudy: Participants will receivereceived ASTX727 once daily on Days 1 through 5 followed by a 23-day [...] tment-free period in a 28-day cycle (Cycle 1). Participants will receivereceived either a high-calorie, high-fat breakfast meal (Arm A) or a [...] meal (Arm B) predose on Day 4. Participants in Arms A and B will receivereceived ASTX727 on Days 1, 2, 3, and 5 in the fasted condition. Par [...] TX727-06 study at the Investigator's discretion, where they will continuecontinued to receive ASTX727. This substudy consists of a 21-day Scre [...]
Study title-53 characters
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
2024-08-30
Study Status v21
Re-verified, no change to tracked fields
2024-07-09
Study Identification, Study Status, Sponsor/Collaborators v20
Lead sponsorAstex Pharmaceuticals, Inc.→Taiho Oncology, Inc.
2024-06-25
3 amendments v17-v19
3 re-verifications since 2024-05-02, no change to tracked fields
2023-08-03
Study Status, Contacts/Locations v16
Study sites32→34
2023-02-16
Study Status, Contacts/Locations v15
Study sites29→32
2022-11-18
Study Status v14
Re-verified, no change to tracked fields
2022-10-05
Study Status, Contacts/Locations v13
Study sites23→29
2022-07-18
Study Status, Sponsor/Collaborators v12
Collaborators-59 characters
Otsuka Pharmaceutical Development & Commercialization, Inc.
2021-12-05
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Enrollment target300→332
Study arms1→3
Eligibility criteria+3,019 characters
Inclusion Criteria for the Main Extension Study: SubjectsParticipants must fulfill all of the following inclusion criteria: Previ [...] tudies ASTX727-01, ASTX727-02, and ASTX727-04) in which the subjectparticipant was treated with ASTX727 and was still on active treatment [...] 727 at the time of study completion as determined by Astex. SubjectParticipant is considered to be benefitting from ASTX727 treatment in t [...] eating investigator at the time of parent study completion (SubjectsParticipants must not be withdrawn from the parent study until eligibility for this study is confirmed). SubjectParticipant is [...] [...]
Secondary endpoints1 to 5 entries
Main Extension Study: Overall Survival status: Time to deathDeath from anyAny causeCause Main Extension Study: Percentage of Participants with Haematological Malignancies Undergoing Conversion to AML Main Extension Study: Number of Participants with Solid Tumors with Disease Status: Complete Response (CR), Partial Response (PR), Stable Disease (SD) Food Effect Substudy: Percentage [...]
Primary endpoints1 to 22 entries
Food Effect Substudy: AUC 0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of Cedazuridine in the Fasted and Fed State Food Effect Substudy: AUC 0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of Cedazuridine-epimer in the Fasted and Fed State Food [...] Safety: Number of participantsParticipants with treatmentTreatment-emergentEmergent adverseAdverse eventsEvents (AEsTEAEs)
Study description+600 characters
TheMain objectivesExtension ofStudy: this extension study are to provide ongoing long-term treatment with ASTX727 for subjects who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study (parent study); to obtain long-term safety information; and to obtain survival information. SubjectsParticipants will attend clinic visits on Day 1 of each 28-day cycle to [...] o be given ASTX727 tablets for Days 1-5 of that dose cycle. SubjectsParticipants should continue to receive the same ASTX727 dose and regime [...] the dose adjustment guidelines of the parent study protocol. Food Effect [...]
Collaborators+59 characters
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study title+21 characters
An Open-Label, Multicenter, ExtensionA Study for SubjectsParticipants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
2021-08-17
Study Status, Conditions, Arms and Interventions, Eligibility v10
Primary completion date2021-03-31→2024-12-31
Completion date2021-03-31→2024-12-31
Eligibility criteria+10 characters
[...] derstands the risks involved in the study. Subject provides writtenlegally effective informed consent before undergoing any study-specific proce [...]
2020-08-03
Study Status v9
Re-verified, no change to tracked fields
2020-07-09
Study Status, Contacts/Locations v8
Study sites24→23
2020-04-14
Study Status, Contacts/Locations v7
Study sites25→24
2020-02-12
Study Status, Contacts/Locations v6
Study sites21→25
2020-01-14
Study Status, Contacts/Locations v5
Study sites15→21
2019-12-13
Study Status, Contacts/Locations v4
Study sites8→15
2019-11-15
Study Status, Contacts/Locations v3
Study sites7→8
2019-10-14
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2019-10-11
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Study sites0→7
2019-09-16
Original filing
Taiho Oncology, Inc.
17 trials monitored
See 2 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Acute Myeloid Leukemia (AML)
1,196 trials monitored
See 63 trials at risk
Myelodysplastic Syndromes (MDS)
685 trials monitored
See 40 trials at risk
and 1 more disease
Extension study to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Taiho (formerly Astex)-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01 \[NCT02103478\], ASTX727-02 \[NCT03306264\], ASTX727-04 \[NCT03813186\]), ASTX727-06 \[NCT04093570\] food effect substudy, ASTX727-17 \[NCT04953897\], and ASTX727-18 \[NCT04953910\] to obtain long-term safety information. The purpose of the Food Effect Substudy was to evaluate the pharmacokinetics (PK) and safety of decitabine and cedazuridine when ASTX727 was given under fed (high-calorie/high-fat meal or low-calorie/low-fat meal) versus fasted conditions. Food Effect Substudy has now completed.
Trial Details
NCT Number NCT04093570
Lead Sponsor Taiho Oncology, Inc.
Conditions Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes
Enrollment 332 participants
Start Date 2019-09-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28