Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
51
Countries
5
Sites
13
Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors
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
- 26 Oct 2021 → ongoing
- Decision date (initial)
- 2024-09-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516291-16-00
- EudraCT number
- 2021-000947-35
- ClinicalTrials.gov
- NCT04953897
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors
| 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 101
- City
- Princeton
- Postcode
- 08540-6231
- Country
- United States
Scientific contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Aram Oganesian
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Aram Oganesian
Locations
5 EU/EEA countries · 13 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 | Ongoing, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 6 | 8 |
| Rest of world
United States, Armenia
|
— | 5 | — |
Investigational sites
Complex Oncological Center Plovdiv EOOD
Department of Medical oncology and oncology diseases in gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
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
Medical Oncology, 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.
NA, Bardosova 2a, Nove mesto, Bratislava
University Clinical Hospital Virgen De La Arrixaca
Hematology Service, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Fundacion Rioja Salud
Oncology, Calle Piqueras 98, 26006, Logrono
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
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
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario Y Politecnico La Fe
Hematology Service, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-09-17 | 2024-11-18 | |||
| Poland | 2023-05-26 | ||||
| Romania | 2023-05-17 | 2023-05-30 | |||
| Slovakia | 2021-10-26 | 2021-11-30 | |||
| Spain | 2022-01-25 | 2022-03-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | Spain | Acceptable with conditions 2024-09-09
|
2024-09-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-15 | Spain | Acceptable 2025-10-13
|
2025-10-17 |