Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
144
Countries
2
Sites
7
Myelodysplastic syndrome (MDS)
Key facts
- Sponsor
- Schrodinger Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 15 Feb 2024 → 15 Aug 2025
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507321-42-00
- ClinicalTrials.gov
- NCT05961839
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myelodysplastic syndrome (MDS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
| 21.1 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Schrodinger Inc.
- Sponsor organisation
- Schrodinger Inc.
- Address
- 1540 Broadway Floor 24th
- City
- New York
- Postcode
- 10036-4039
- Country
- United States
Scientific contact point
- Organisation
- Schrodinger Inc.
- Contact name
- Clinical Trial Team
Public contact point
- Organisation
- Schrodinger Inc.
- Contact name
- Clinical Trial Team
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 23 | 3 |
| Spain | Ended | 30 | 4 |
| Rest of world
United States
|
— | 91 | — |
Investigational sites
Hopital Saint Louis
Hematology Department, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli-Calmettes
Hematology Department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut Gustave Roussy
Hematology Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitario 12 De Octubre
Hematology Service, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital San Pedro De Alcantara
Hematology Service, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Y Politecnico La Fe
Hematology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Fundacion Jimenez Diaz
START Madrid-FJD, Phase I Clinical Trials Unit, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| France | 2024-04-23 | 2024-05-29 | 2025-08-14 | ||
| Spain | 2024-02-15 | 2024-03-20 | 2025-08-14 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-03 | Spain | Acceptable 2024-01-29
|
2024-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-07 | Acceptable | 2024-03-19 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-08 | Spain | Acceptable 2024-06-13
|
2024-06-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-19 | Spain | Acceptable 2024-06-13
|
2024-07-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-04 | Spain | Acceptable 2024-06-13
|
2024-09-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-01 | Spain | Acceptable 2024-06-13
|
2024-10-01 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-15 | Spain | Acceptable 2025-04-01
|
2025-04-01 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-12 | Spain | Acceptable 2025-04-01
|
2025-05-12 |