Clinical trial • Phase II • Oncology

Decitabine; Cedazuridine for Acute myeloid leukaemia | Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Solid tumor

Phase II trial of Decitabine; Cedazuridine for Acute myeloid leukaemia | Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Solid tumor.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukaemia | Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Solid tumor
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-09-2024
First CTIS Authorization Date
04-10-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 20 sites in Germany, Slovakia, Poland and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
271

Eligibility

Recruits 271 Vulnerable population is selected (isVulnerablePopulationSelected = true). Inclusion criteria require that the subject "is able to understand and comply with the study procedures and understands the risks involved in the study." and that the "Subject provides legally effective informed consent before undergoing any study-specific procedure." No information on assent or proxy consent for minors is provided in the available documents..

Pregnancy Exclusion
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.
Vulnerable Population
Vulnerable population is selected (isVulnerablePopulationSelected = true). Inclusion criteria require that the subject "is able to understand and comply with the study procedures and understands the risks involved in the study." and that the "Subject provides legally effective informed consent before undergoing any study-specific procedure." No information on assent or proxy consent for minors is provided in the available documents.

Inclusion criteria

  • {"criterion_text":"- 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.\n- 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.)\n- Subject is able to understand and comply with the study procedures and understands the risks involved in the study.\n- Subject provides legally effective informed consent before undergoing any study-specific procedure.\n- 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

  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- Safety as measured by AEs","definition_or_measurement_approach":"As stated in protocol: safety measured by adverse events (AEs)."}

Recruitment

Planned Sample Size
271
Recruitment Window Months
78
Consent Approach
"Subject provides legally effective informed consent before undergoing any study-specific procedure." Local subject information and informed consent forms are provided for multiple countries/languages (documents listed for Germany, Slovakia, Poland, Hungary, Bulgaria, Romania, Spain and others). Consent is provided by the subject (no proxy/assent process for minors is described).

Geography

Total Number Of Sites
20
Total Number Of Participants
100

Germany

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
0
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Not applicable
Contact Person Name
Friederike Wortmann
Contact Person Email
friederike.wortmann@uksh.de
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Not applicable
Contact Person Name
Juergen Krauter

Slovakia

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
467
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Summit Clinical Research s.r.o.
Department Name
Not applicable
Contact Person Name
Monika Matejková
Contact Person Email
matejkova.monika@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
425
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Department Name
Not applicable
Contact Person Name
Piotr Napora
Contact Person Email
napora.piotr@cbk.wroc.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Not applicable
Contact Person Name
Michal Andrzej Taszner
Contact Person Email
mtaszner@uck.gda.pl

Austria

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
437
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Klinik Hietzing
Department Name
Not applicable
Contact Person Name
Klaus Geissler
Contact Person Email
Geissler.Klaus@gmx.at

Hungary

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
504
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
University Of Debrecen
Department Name
Hematologia
Contact Person Name
Árpád Illés
Contact Person Email
illesarpaddr@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
472
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
First Department of Clinical Hematology at Clinic of Clinical Hematology
Contact Person Name
Martin Donchev
Contact Person Email
martin.donchev@abv.bg
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
Dept of Med Onco and Gastro Onco with beds for daily systemic antitumor therapy-12hrs-med onco
Contact Person Name
Antoaneta Tomova
Contact Person Email
dr.tomova@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
461
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Radiotherapy
Contact Person Name
Tudor-Eliade Ciuleanu
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology
Contact Person Name
Laurenția Nicoleta Galeș

Spain

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
458
Number Of Sites
9
Number Of Participants
31

Sites

Site Name
Hospital San Pedro
Department Name
Not applicable
Contact Person Name
Maria-Jose de Miguel Luken
Contact Person Email
maria.demiguel@startmadrid.com
Site Name
Hospital Hm Nou Delfos
Department Name
Not applicable
Contact Person Name
Tatiana Hernandes Guerrero
Site Name
Hospital Universitario 12 De Octubre
Department Name
Not applicable
Contact Person Name
Antonia Rodríguez Izquierdo
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Not applicable
Contact Person Name
Jose Luis Alonso Romero
Contact Person Email
josel.alonso2@carm.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Not applicable
Contact Person Name
Eduardo Jose Salido Fierrez
Contact Person Email
edujsalido@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Not applicable
Contact Person Name
Jaime Feliu Batlle
Contact Person Email
jaime.feliu@uam.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Not applicable
Contact Person Name
Juan José Soto
Contact Person Email
juanj.soto@startresearch.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Not applicable
Contact Person Name
Gala Vega Achabal
Contact Person Email
gala.vega@startmadrid.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Not applicable
Contact Person Name
Serafin Morales Murillo
Contact Person Email
serafinmorales01@gmail.com

Sponsor

Primary sponsor

Full Name
Taiho Oncology Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties codes: [14]
Name
Endpoint Clinical Inc.
Responsibilities
IVRS randomization (sponsorDuties code 15)
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1, 12, 2, 8]
Name
ARENSIA Exploratory Medicine GmbH
Responsibilities
sponsorDuties codes: [5]

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Arensia Exploratory Medicine S.R.L.","duties_or_roles":"sponsorDuties codes: [12, 2, 5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties: [15] (IVRS randomization)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1, 12, 2, 8]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"sponsorDuties codes: [5]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
ASTX727
Active Substance
Decitabine; Cedazuridine
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus 1
Maximum Dose
Max daily dose 135 mg; max total dose amount 4050 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.