Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
24
Countries
3
Sites
8
Acute Myeloid Leukemia
Key facts
- Sponsor
- Curis Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Dec 2023 → ongoing
- Decision date (initial)
- 2023-10-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Curis Inc.
- Sponsor organisation
- Curis Inc.
- Address
- 128 Spring Street Suite 500 Building C
- City
- Lexington
- Postcode
- 02421-7800
- Country
- United States
Scientific contact point
- Organisation
- Curis Inc.
- Contact name
- Sr Medical Director, Clinical Development
Public contact point
- Organisation
- Curis Inc.
- Contact name
- Medical Affairs
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 14 | 4 |
| Italy | Ongoing, recruitment ended | 5 | 2 |
| Spain | Ended | 5 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Jena KöR
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
University Medical Center Hamburg-Eppendorf
Department of Medicine 2 Polyclinic, Martinistrasse 52, Eppendorf, Hamburg
Technische Universitat Dresden
Medizinische Fakultät Carl Gustav Carus Nationales Centrum für Tumorerkrankungen Dresden Early Cli, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Divisione di Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Divisione di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
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 |
|---|---|---|---|---|---|
| Germany | 2024-03-15 | 2026-04-30 | 2024-03-15 | 2026-02-10 | |
| Italy | 2024-05-27 | 2024-05-27 | 2026-02-10 | ||
| Spain | 2023-12-05 | 2026-05-08 | 2023-12-05 | 2026-02-10 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | Spain | Acceptable 2023-10-20
|
2023-10-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-07 | Acceptable | 2023-12-04 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-15 | Spain | Acceptable 2024-05-30
|
2024-05-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-19 | Spain | Acceptable | 2024-08-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-30 | Acceptable | 2024-09-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-25 | Acceptable | 2024-10-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-30 | Spain | Acceptable 2025-03-13
|
2025-03-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-12 | Acceptable | 2025-06-20 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-27 | Spain | Acceptable 2026-05-14
|
2026-05-15 |