Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
6
relapsed/refractory hematologic malignancies
Key facts
- Sponsor
- Vanda Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Jan 2021 → ongoing
- Decision date (initial)
- 2024-12-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518454-17-00
- EudraCT number
- 2019-004828-37
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
relapsed/refractory hematologic malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vanda Pharmaceuticals Inc.
- Sponsor organisation
- Vanda Pharmaceuticals Inc.
- Address
- 2200 Pennsylvania Avenue Northwest Suite 300
- City
- Washington
- Postcode
- 20037-1709
- Country
- United States
Scientific contact point
- Organisation
- Vanda Pharmaceuticals Inc.
- Contact name
- Clinical – Vanda Pharmaceuticals
Public contact point
- Organisation
- Vanda Pharmaceuticals Inc.
- Contact name
- Clinical – Vanda Pharmaceuticals
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 30 | 6 |
| Rest of world
United States
|
— | 30 | — |
Investigational sites
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Oddział Onkologii Klinicznej, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia Hematologia Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Hematologii, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Szpital Wojewodzki W Opolu Sp. z o.o.
Oddział Kliniczny Hematologii, Onkologii Hematologicznej i Chorób Wewnętrznych, Ul. Katowicka 64, 45-061, Opole
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
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 |
|---|---|---|---|---|---|
| Poland | 2021-01-08 | 2021-01-08 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-13 | Poland | Acceptable 2024-12-19
|
2024-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Poland | Acceptable | 2025-03-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-16 | Poland | Acceptable | 2025-09-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-25 | Poland | Acceptable 2026-05-20
|
2026-05-25 |