Clinical trial • Phase I | Phase II | Phase III • Haematology|Rare Disease

AZACITIDINE, CEDAZURIDINE for Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Acute myeloid leukaemia

Phase I | Phase II | Phase III trial of AZACITIDINE, CEDAZURIDINE for Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Acute myeloid leukaemi…

Overview

Trial Therapeutic Area
Haematology|Rare Disease
Trial Disease
Myelodysplastic syndrome | Chronic myelomonocytic leukaemia | Acute myeloid leukaemia
Trial Stage
Phase I | Phase II | Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-02-2025
First CTIS Authorization Date
30-05-2025

Trial design

Randomised, open-label, vidaza 25 mg/ml powder for suspension for injection (azacitidine) subcutaneous (sc) at 75 mg/m2/day (daily dosing for 7 days per 28-day cycle) versus astx030 (oral fixed dose combination of cedazuridine and azacitidine) (astx030 dosing per protocol / fdc; exact oral dose levels not specified in ctis summary).-controlled, crossover, adaptive Phase I | Phase II | Phase III trial in Germany, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Vidaza 25 mg/ml powder for suspension for injection (azacitidine) subcutaneous (SC) at 75 mg/m2/day (daily dosing for 7 days per 28-day cycle) versus ASTX030 (oral fixed dose combination of cedazuridine and azacitidine) (ASTX030 dosing per protocol / FDC; exact oral dose levels not specified in CTIS summary).
Adaptive
True, includes a Phase 1 dose-escalation (Stage A) followed by dose expansion (Stage B) and a Phase 2 dose confirmation; Phase 1 dose-escalation rules are referenced (dose escalation design) though specific numeric escalation rules are not provided in the CTIS JSON.
Crossover
Yes
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
200

Eligibility

Recruits 200 Vulnerable populations not selected. Inclusion criterion states: '11. Capable of giving legally effective informed consent. and willing to participate in the study.' Participants must be ≥18 years; no provisions for assent or minor enrollment are provided..

Pregnancy Exclusion
10. Follow contraceptive barrier requirements per protocol
Vulnerable Population
Vulnerable populations not selected. Inclusion criterion states: '11. Capable of giving legally effective informed consent. and willing to participate in the study.' Participants must be ≥18 years; no provisions for assent or minor enrollment are provided.

Inclusion criteria

  • {"criterion_text":"- 1. Must be ≥18 years\n- 8. Able to swallow the number of capsules required within 10-mins and can tolerate 4 hours of fasting.\n- 9. Life expectancy >= 12 weeks.\n- 10. Follow contraceptive barrier requirements per protocol\n- 11. Capable of giving legally effective informed consent. and willing to participate in the study.\n- 2. Confirmed MDS or CMML and a candidate to receive and benefit from single-agent azacitidine according to French-American-British myelodysplastic syndrome subtypes: or MDS with intermediate-2 or high risk MDS according to the IPSS (Greenberg P, et al. Blood. 1997;89:2079-2088)\n- 3. ECOG 0 or 1\n- 4. Adequate organ function : a. Total or direct bilirubin ≤2 × ULN; AST/ SGOT and ALT/SGPT ≤2.5 × ULN. b. Calculated CrCl >50 mL/min by Cockcroft-Gault formula or other medically acceptable formulas.\n- 5. For participants with prior allogeneic stem cell transplant, has no evidence of graft vs host disease and must be ≥3 weeks off systemic immunosuppressive therapy before study start.\n- 6. No major surgery within 3 weeks before treatment initiation.\n- 7. No cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before treatment initiation"}

Exclusion criteria

  • {"criterion_text":"- 1. Active, uncontrolled gastric or duodenal ulcer.\n- 4. Known positive for Hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months of screening\n- 5. Life-threatening illness, uncontrolled medical condition or organ system dysfunction, or other reasons that, could compromise the participant's safety, interfere with the absorption or metabolism of ASTX030, or the integrity of study outcomes.\n- 6.History of other malignancies, except certain adequately treated and/or controlled cancers, or early-stage cases not requiring therapy.\n- 7. Extramedullary disease in MDS/MPN, including palpable hepatomegaly or splenomegaly\n- 8. Prior treatment with > 1 cycle of decitabine or azacitidine\n- 9. Treated with any investigational therapy within 2 weeks, or 5 half-lives, whichever is longer, before treatment initiation , or has ongoing clinically significant AEs from previous treatment with investigational agent\n- 10. Cannot discontinue treatment with drugs that delay gastric emptying (GLP-1 and/or GIP agonists in Cycles 1 & 2.\n- 11. Known hypersensitivity to cedazuridine or azacitidine or any excipients.\n- 2. Poor medical risk due to any uncontrolled systemic diseases or active uncontrolled bacterial, viral, or fungal infections.\n- 3. Known HIV infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- • Ratio of azacitidine total cycle AUC 0-24 exposures after oral ASTX030 over SC azacitidine at 75 mg/m2/day","definition_or_measurement_approach":"Establish azacitidine AUC equivalence (90% CI 0.8, 1.25) between the final selected dose of ASTX030 and SC azacitidine at 75 mg/m2/day across BSA ranges; measured as total cycle AUC0-24 of azacitidine."}

Secondary endpoints

  • {"endpoint_text":"- 1 TEAEs including SAEs","definition_or_measurement_approach":"Treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs); safety and tolerability assessment."}
  • {"endpoint_text":"- 2 Percent LINE-1 demethylation change from baseline between SC azacitidine and ASTX030 in Cycles 1 and 2","definition_or_measurement_approach":"Percent change from baseline in LINE-1 demethylation comparing SC azacitidine and ASTX030 in treatment Cycles 1 and 2 (biomarker DNAmethylation assessment)."}
  • {"endpoint_text":"- 3 Participants with MDS or CMML: - Clinical response rate - AML-free survival - Duration of response - OS - Time to response - Transfusion independence","definition_or_measurement_approach":"Clinical activity endpoints for participants with MDS or CMML including clinical response rate, AML-free survival, duration of response, overall survival (OS), time to response, and transfusion independence as defined in protocol clinical response criteria."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include electronic communications (e.g. 'L2_CZ_Other Subject Material_Scout Email Communication_Czech'), scout email communications and study brochures indicating digital/email recruitment channels.
Planned Sample Size
200
Recruitment Window Months
29
Consent Approach
Informed consent is required from participants themselves: inclusion criterion '11. Capable of giving legally effective informed consent. and willing to participate in the study.' Subject information and informed consent form (SIS-ICF) documents are provided per country (examples: German, Czech, French, Spanish, Italian, Hungarian, Polish versions listed). Separate ICF materials include main ICF, pregnancy/partner ICF, genetic/optional research information and scout-specific materials; consent is participant-provided, no assent procedures for minors are described (participants must be ≥18).

Methods

  • Site-based recruitment at participating hospitals/clinics (trial sites listed per country; target patients are adults with MDS/CMML/AML).
  • Country-specific recruitment procedures documented (K1 recruitment procedure documents present for DE, CZ, FR, ES, IT, PL and others).
  • Use of a vendor labelled 'Scout' (Scout Clinical) for participant outreach/support (materials include 'Scout Email Communication' and 'Scout Study Brochure' in Czech and other countries).
  • Provision of patient travel reimbursement (Scout Clinical listed with duty 'Patient travel reimbursement').

Geography

Total Number Of Sites
43
Total Number Of Participants
588

Germany

Earliest CTIS Part Ii Submission Date
28-04-2025
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
233
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Jürgen Krauter
Principal Investigator Email
j.krauter@klinikum-braunschweig.de
Contact Person Name
Jürgen Krauter
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Hämatologie, Onkologie, Rheumatologie
Principal Investigator Name
Tim Sauer
Principal Investigator Email
tim.sauer@med.uni-heidelberg.de
Contact Person Name
Tim Sauer
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Krukenberg-Cancer Center Halle
Principal Investigator Name
Haifa Kathrin Al-Ali
Principal Investigator Email
Haifa.al-ali@uk-halle.de
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
Haifa.al-ali@uk-halle.de
Site Name
Medical Center - University Of Freiburg
Department Name
Hämatologie/Onkologie/Stammzelltranspantation
Principal Investigator Name
Michael Lübbert
Principal Investigator Email
Michael.luebbert@uniklinik-freiburg.de
Contact Person Name
Michael Lübbert

Czechia

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
227
Number Of Sites
4
Number Of Participants
76

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Principal Investigator Name
Jiří Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiří Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I.Interní klinika - klinika hematologie
Principal Investigator Name
Anna Jonášová
Principal Investigator Email
anna.jonasova@vfn.cz
Contact Person Name
Anna Jonášová
Contact Person Email
anna.jonasova@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika Hematoonkologie FNO a LF OU
Principal Investigator Name
Zdeněk Kořístek
Principal Investigator Email
zdenek.koristek@fno.cz
Contact Person Name
Zdeněk Kořístek
Contact Person Email
zdenek.koristek@fno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hematologická klinika
Principal Investigator Name
Jan Novák
Principal Investigator Email
jan.novak@fnkv.cz
Contact Person Name
Jan Novák
Contact Person Email
jan.novak@fnkv.cz

France

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
229
Number Of Sites
3
Number Of Participants
68

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Département d’hématologie
Principal Investigator Name
Thomas Cluzeau
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Unité de Médecine Interne
Principal Investigator Name
Thibault COMONT
Principal Investigator Email
Comont.Thibault@iuct-oncopole.fr
Contact Person Name
Thibault COMONT
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département d’hématologie et d’immunologie
Principal Investigator Name
Pierre Fenaux
Principal Investigator Email
Pierre.fenaux@aphp.fr
Contact Person Name
Pierre Fenaux
Contact Person Email
Pierre.fenaux@aphp.fr

Hungary

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
255
Number Of Sites
4
Number Of Participants
42

Sites

Site Name
Semmelweis University
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Zsolt NAGY
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt NAGY
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Haematológia
Principal Investigator Name
Eszter SÁRI
Principal Investigator Email
sarieszter@gmail.com
Contact Person Name
Eszter SÁRI
Contact Person Email
sarieszter@gmail.com
Site Name
University Of Debrecen
Department Name
B épület, Hematológia
Principal Investigator Name
Árpád ILLÉS
Principal Investigator Email
illesarpaddr@gmail.com
Contact Person Name
Árpád ILLÉS
Contact Person Email
illesarpaddr@gmail.com
Site Name
University Of Szeged
Department Name
Hematológia
Principal Investigator Name
Zita BORBÉNYI
Principal Investigator Email
borbenyizita@gmail.com
Contact Person Name
Zita BORBÉNYI
Contact Person Email
borbenyizita@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
214
Number Of Sites
16
Number Of Participants
192

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Haematology
Principal Investigator Name
Maria Diez Campelo
Principal Investigator Email
mdiezcampelo@usal.es
Contact Person Name
Maria Diez Campelo
Contact Person Email
mdiezcampelo@usal.es
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Haematology and haemotherapy
Principal Investigator Name
Rosa Coll
Principal Investigator Email
rcoll@iconcologia.net
Contact Person Name
Rosa Coll
Contact Person Email
rcoll@iconcologia.net
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Haematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Haematology
Principal Investigator Name
Teresa Bernal del Castillo
Principal Investigator Email
bernalmaria@uniovi.es
Contact Person Name
Teresa Bernal del Castillo
Contact Person Email
bernalmaria@uniovi.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Haematology
Principal Investigator Name
Elvira Mora Castera
Principal Investigator Email
mora_elv@gva.es
Contact Person Name
Elvira Mora Castera
Contact Person Email
mora_elv@gva.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Haematology
Principal Investigator Name
Pedro Antonio Gonzalez
Principal Investigator Email
pedroa.gonzalez.sspa@juntadeandalucia.es
Contact Person Name
Pedro Antonio Gonzalez
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Haematology
Principal Investigator Name
Gabriela Rodriguez Macías
Principal Investigator Email
gabriela.rodriguez@salud.madrid.org
Contact Person Name
Gabriela Rodriguez Macías
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Haematology
Principal Investigator Name
Ana Alfonso Pierola
Principal Investigator Email
aalfonso@unav.es
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
MD Anderson Cancer Center (Madrid)
Department Name
Haematology
Principal Investigator Name
Adolfo De la Fuente
Principal Investigator Email
afuente@mdanderson.es
Contact Person Name
Adolfo De la Fuente
Contact Person Email
afuente@mdanderson.es
Site Name
Hospital Universitario La Paz
Department Name
Haematology
Principal Investigator Name
Maria Raquel de Paz Arias
Principal Investigator Email
depazraquel@gmail.com
Contact Person Name
Maria Raquel de Paz Arias
Contact Person Email
depazraquel@gmail.com
Site Name
Hospital Quironsalud Malaga
Department Name
Haematology
Principal Investigator Name
Augustin Hernandez Sánchez
Principal Investigator Email
agustin.hernandez@quironsalud.es
Contact Person Name
Augustin Hernandez Sánchez
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Haematology
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
bxicoy@iconcologia.net
Contact Person Name
Blanca Xicoy Cirici
Contact Person Email
bxicoy@iconcologia.net
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Haematology
Principal Investigator Name
Montserrat Arnan Sangerman
Principal Investigator Email
marnan@iconcologia.net
Contact Person Name
Montserrat Arnan Sangerman
Contact Person Email
marnan@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Haematology
Principal Investigator Name
David Valcarcel Ferreiras
Principal Investigator Email
dvalcarcelct@vhio.net
Contact Person Name
David Valcarcel Ferreiras
Contact Person Email
dvalcarcelct@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Haematology
Principal Investigator Name
Marina Diaz Beyá
Principal Investigator Email
diazbeya@clinic.cat
Contact Person Name
Marina Diaz Beyá
Contact Person Email
diazbeya@clinic.cat
Site Name
Hospital San Pedro De Alcantara
Department Name
Haematology
Principal Investigator Name
Juan Miguel Bergua Burgues
Principal Investigator Email
jmberguaburg@gmail.com
Contact Person Name
Juan Miguel Bergua Burgues
Contact Person Email
jmberguaburg@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
22-04-2025
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
251
Number Of Sites
9
Number Of Participants
125

Sites

Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
SCDU Ematologia e Terapie cellulari
Principal Investigator Name
Daniela Cilloni
Principal Investigator Email
Daniela.cilloni@unito.it
Contact Person Name
Daniela Cilloni
Contact Person Email
Daniela.cilloni@unito.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Hematology
Principal Investigator Name
Adriano Venditti
Principal Investigator Email
Adriano.venditti@uniroma2.it
Contact Person Name
Adriano Venditti
Contact Person Email
Adriano.venditti@uniroma2.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology and Hematology
Principal Investigator Name
Giovanni Marconi
Principal Investigator Email
Giovanni.marconi2@unibo.it
Contact Person Name
Giovanni Marconi
Contact Person Email
Giovanni.marconi2@unibo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Ematologia
Principal Investigator Name
Nicola Fracchiolla
Principal Investigator Email
Nicola.fracchiolla@policlinico.mi.it
Contact Person Name
Nicola Fracchiolla
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Experimental and Clinical Medicine
Principal Investigator Name
Valeria Santini
Principal Investigator Email
valeria.santini@unifi.it
Contact Person Name
Valeria Santini
Contact Person Email
valeria.santini@unifi.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Principal Investigator Name
Cristina Papayannidis
Principal Investigator Email
Cristina.papayannidis@unibo.it
Contact Person Name
Cristina Papayannidis
Contact Person Email
Cristina.papayannidis@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
Massimo.breccia@uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
Massimo.breccia@uniroma1.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Ematologia
Principal Investigator Name
Ernesta Audisio
Principal Investigator Email
eaudisio@cittadellasalute.to.it
Contact Person Name
Ernesta Audisio
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Ematologia
Principal Investigator Name
Monia Lunghi
Principal Investigator Email
Monia.lunghi@med.unipo.it
Contact Person Name
Monia Lunghi
Contact Person Email
Monia.lunghi@med.unipo.it

Poland

Earliest CTIS Part Ii Submission Date
01-05-2025
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
298
Number Of Sites
3
Number Of Participants
45

Sites

Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Hematologii i Transplantologii Szpiku
Principal Investigator Name
Adam Witkowski
Principal Investigator Email
awitkowski@szpitalepomorskie.eu
Contact Person Name
Adam Witkowski
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii i Transplantologii – Klinika Hematologii
Principal Investigator Name
Agnieszzka Wierzbowska
Principal Investigator Email
agnieszka.wierzbowska@umed.lodz.pl
Contact Person Name
Agnieszzka Wierzbowska
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddział Hematoonkologii, Transplantacji Szpiku i Chemioterapii
Principal Investigator Name
Marek Hus
Principal Investigator Email
hematoonkologia@spsk1.lublin.pl
Contact Person Name
Marek Hus

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,12,2,5,8]
Name
Endpoint Clinical Inc.
Responsibilities
sponsorDuties codes: [3]

Third parties

  • {"country":"United States","full_name":"Epigendx Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Genomic Testing Cooperative Lca","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,2,5,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: [15]; value: Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Azacitidine, Cedazuridine (ASTX030 FDC)
Active Substance
AZACITIDINE, CEDAZURIDINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Vidaza 25 mg/ml powder for suspension for injection
Active Substance
AZACITIDINE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketingAuthorisation EU/1/08/488/001)
Starting Dose
75 mg/m2/day
Frequency
Daily for 7 days per 28-day cycle
Maximum Dose
525.00 mg/m2 (total per cycle)
Investigational Product Name
Azacitidine (capsule)
Active Substance
AZACITIDINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Combination Treatment
Yes

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