Study to Evaluate the PK and Safety of Oral Decitabine and Cedazuridine in Cancer Patients with Hepatic Impairment

Start 22 Oct 2021 · Status Ongoing, recruitment ended · 5 EU/EEA countries · 14 sites · Protocol ASTX727-18

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruitment ended

Participants planned 64

Countries 5

Sites 14

Myelodysplastic syndrome (MDS)

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: 22 Oct 2021 → ongoing
Decision date (initial): 2024-09-16
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-516292-33-00
EudraCT number: 2021-000966-13

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Myelodysplastic syndrome (MDS)

Version	Level	Code	Term	System organ class
21.1	LLT	10065252	Solid tumor	10029104
21.1	PT	10000880	Acute myeloid leukaemia	100000004864
27.0	PT	10028533	Myelodysplastic syndrome	100000004864

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: Medical Monitor

Public contact point

Organisation: Taiho Oncology Inc.
Contact name: Medical Monitor

Locations

5 EU/EEA countries · 14 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	10	1
Poland	Authorised, recruiting	10	1
Romania	Ongoing, recruiting	10	2
Slovakia	Authorised, recruiting	10	1
Spain	Ongoing, recruiting	10	9
Rest of world United States, Armenia	—	14	—

Investigational sites

Bulgaria

1 site · Ended

Complex Oncological Center Plovdiv EOOD

Department of Medical oncology and oncology diseases in gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv

Poland

1 site · Authorised, recruiting

Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.

N/A, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw

Romania

2 sites · Ongoing, recruiting

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest

Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca

Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca

Slovakia

1 site · Authorised, recruiting

Summit Clinical Research s.r.o.

N/A, Nove Mesto, Bardosova 2a, Bratislava

Spain

9 sites · Ongoing, recruiting

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida

Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida

University Clinical Hospital Virgen De La Arrixaca

Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia

Hospital Universitario Y Politecnico La Fe

Hematology Service, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Hm Nou Delfos

Oncology, Avinguda De Vallcarca 151, 08023, Barcelona

Fundacion Rioja Salud

Oncology, Calle Piqueras 98, 26006, Logrono

Hospital Universitario La Paz

Oncology, Paseo De La Castellana 261, 28046, Madrid

Hospital Universitario Fundacion Jimenez Diaz

Hematology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital Universitario Hm Sanchinarro

Oncology, Calle Ona 10, 28050, Madrid