Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
371
Countries
8
Sites
20
Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or solid tumors
To provide ongoing long-term treatment with ASTX727 for subjects who were benefiting from ASTX727 treatment in a previous Taiho sponsored clinical study. To obtain long-term safety information.
Key facts
- Sponsor
- Taiho Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Mar 2022 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516293-29-01
- EudraCT number
- 2018-003942-18
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
To provide ongoing long-term treatment with ASTX727 for subjects who were benefiting from ASTX727 treatment in a previous Taiho sponsored clinical study.
To obtain long-term safety information.
Conditions and MedDRA coding
Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 21.0 | PT | 10009018 | Chronic myelomonocytic leukaemia | 100000004864 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Informed consent and eligibility assessment
|
Not Applicable | None | ||
| 2 | Treatment 28-D cycles
|
Not Applicable | None | ||
| 3 | Treatment discontinuation Treatment Discontinuation Visit
|
Not Applicable | None | ||
| 4 | Safety follow-up safety follow-up evaluation after the last ASTX727 treatment or when the subject begins an alternative anticancer treatment, whichever is first.
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516292-33-00 | A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients with Moderate and Severe Hepatic Impairment | Taiho Oncology Inc. |
| 2024-516293-29-00 | An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose) | Taiho Oncology Inc. |
| 2024-516291-16-00 | A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients with Severe Renal Impairment and Cancer Patients with Normal Renal Function | Taiho Oncology Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Previous participation in a Taiho-sponsored ASTX727 clinical trial in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by the Sponsor.
- Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
- Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
- Subject provides legally effective informed consent before undergoing any study-specific procedure.
- Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control (with a failure rate of <1% per year; with low user dependency) during the substudy and for 6 months after the last dose of study treatment, agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period, and must agree not to become pregnant for 6 months after completing treatment; Men with female partners of childbearing potential must agree to use a condom and advise their partners to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) while receiving treatment with ASTX727. For at least 3 months after completing treatment, men must agree not to father a child while receiving ASTX727 and for at least 3 months after completing treatment.
Exclusion criteria 1
- Any subject who, in the opinion of the investigator, may have other conditions, or for whom safety data from parent study participation suggest the risks of continuing treatment with ASTX727 may outweigh the benefits.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety as measured by AEs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11224172 · Product
- Active substance
- Decitabine
- Substance synonyms
- 5-AZA-2'-DEOXYCYTIDINE, 4-AMINO-1-(2-DEOXY-.BETA.-D-ERYTHRO-PENTOFURANOSYL)-S-TRIAZIN-2(1H)-ONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 135 mg milligram(s)
- Max total dose
- 4050 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TAIHO ONCOLOGY INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Taiho Oncology Inc.
- Sponsor organisation
- Taiho Oncology Inc.
- Address
- 101 Carnegie Center Suite 300
- City
- Princeton
- Postcode
- 08540-6231
- Country
- United States
Scientific contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Hamdy Elsayed
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Hamdy Elsayed
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| Arensia Exploratory Medicine S.R.L. ORG-100017164
|
Bucharest, Romania | Code 12, Code 2, Code 5 |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 8 |
| ARENSIA Exploratory Medicine GmbH ORG-100049248
|
Duesseldorf, Germany | Code 5 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
8 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 8 | 1 |
| Bulgaria | Ongoing, recruiting | 7 | 2 |
| Germany | Ended | 2 | 2 |
| Hungary | Ongoing, recruiting | 6 | 1 |
| Poland | Authorised, recruitment pending | 20 | 2 |
| Romania | Ongoing, recruiting | 16 | 2 |
| Slovakia | Authorised, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 31 | 9 |
| Rest of world
United States, Armenia, Canada
|
— | 271 | — |
Investigational sites
Complex Oncological Center Plovdiv EOOD
Dept of Med Onco and Gastro Onco with beds for daily systemic antitumor therapy-12hrs-med onco, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
First Department of Clinical Hematology at Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Staedtisches Klinikum Braunschweig gGmbH
Not applicable, Celler Strasse 38, 38114, Brunswick
Universitaetsklinikum Schleswig-Holstein AöR
Not applicable, Ratzeburger Allee 160, 23538, Luebeck
Uniwersyteckie Centrum Kliniczne
Not applicable, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Not applicable, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Radiotherapy, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest
Summit Clinical Research s.r.o.
Not applicable, Bardosova 2a, Nove Mesto, Bratislava
Hospital San Pedro
Not applicable, Calle Piqueras 98, 26006, Logrono
Hospital Hm Nou Delfos
Not applicable, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Not applicable, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Not applicable, Calle Ona 10, 28050, Madrid
University Clinical Hospital Virgen De La Arrixaca
Not applicable, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
University Clinical Hospital Virgen De La Arrixaca
Not applicable, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario La Paz
Not applicable, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Not applicable, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario 12 De Octubre
Not applicable, Avenida De Cordoba Sn, 28041, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-08-30 | 2022-09-30 | |||
| Bulgaria | 2023-03-01 | 2023-03-15 | |||
| Germany | 2023-03-02 | 2025-01-05 | 2023-03-06 | 2023-03-27 | |
| Hungary | 2023-03-01 | 2023-03-14 | |||
| Romania | 2023-07-05 | 2023-10-25 | |||
| Slovakia | 2022-03-17 | ||||
| Spain | 2022-04-26 | 2022-06-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 56 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516293-29-00_redacted | 8.0 |
| Recruitment arrangements (for publication) | K_DE_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangement_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_RO_Recruitment and informed consent form procedure_clean | 2 |
| Recruitment arrangements (for publication) | K_RO_Recruitment and informed consent form procedure_TC | 2 |
| Recruitment arrangements (for publication) | K_RO_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_AT_Recruitment Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment Procedure_Bulgarian | 1.1 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 2.0 |
| Recruitment arrangements (for publication) | K1_SK_Recruitment Procedure | 2.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Main_German_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnancy_German_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian | 7.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy Partner | 5.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy Partner_Bulgarian | 5.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Scout_Bulgarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main ICF_German_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy_German | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main Extension ICF_Hungarian | 4.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Partner Pregnancy CF_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Partner Pregnancy_Hungarian | 5.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnancy Follow-up CF_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnancy Follow-up_Hungarian | 5.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Scout ICF_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_PP_Polish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main _EN_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_RO_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_EN_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_RO_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Data Privacy_Slovak | 7.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Main_Slovak | 7.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Participant Partner Pregnancy_Slovak | 6.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Subject card_Hungarian | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024 516293-29_Bulgarian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024 516293-29_Hungarian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024 516293-29_Polish | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-516293-29 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-516293-29_Romanian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-516293-29_Slovak | 8.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2024-516293-29_Spanish | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29 | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_1 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Bulgarian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_German | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Hungarian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Polish | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Romanian | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Slovak | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516293-29_Spanish | 8.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-04 | Slovakia | Acceptable 2024-10-03
|
2024-10-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-13 | 2025-02-11 | ||
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-26 | Slovakia | 2025-03-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-25 | Slovakia | Acceptable 2025-08-25
|
2025-08-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-30 | Slovakia | Acceptable 2025-12-23
|
2026-01-12 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-12 | Slovakia | Acceptable 2025-12-23
|
2026-03-12 |