Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
216
Countries
6
Sites
23
Subjects with newly diagnosed WHO Grade IV glioblastoma (ndGBM) who have undergone complete or partial tumor resection
Key facts
- Sponsor
- Celgene Corp., Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 6 Jul 2020 → 10 Jul 2024
- Decision date (initial)
- 2024-04-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511171-15-00
- EudraCT number
- 2019-004122-25
- WHO UTN
- U1111-1248-0496
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Subjects with newly diagnosed WHO Grade IV glioblastoma (ndGBM) who have undergone complete or partial tumor resection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
6 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 19 | 3 |
| Italy | Ended | 50 | 3 |
| Netherlands | Ended | 20 | 3 |
| Norway | Ended | 7 | 1 |
| Spain | Ended | 109 | 10 |
| Sweden | Ended | 11 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Odense University Hospital
Oncology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Humanitas Research Hospital
Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
San Raffaele Hospital
Oncology, Via Olgettina 58, 20132, Milan
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Leids Universitair Medisch Centrum (LUMC)
oncologie, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Utrecht
medische oncologie, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
interne oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Uppsala University Hospital
Kliniska forsknings- och utvecklingsenheten, Onkologikliniken, Akademiska Sjukhuset, Uppsala, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
Kliniska forskningsenheten, entréplan Barngatan 4, 221 85 Lund, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Kliniska prövningsenheter, Blå stråket 2, 413 45 Göteborg, Bla Straket 5, 413 46, Goteborg
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 |
|---|---|---|---|---|---|
| Denmark | 2022-06-03 | 2022-06-15 | 2023-03-24 | ||
| Italy | 2020-08-12 | 2020-09-01 | 2023-03-25 | ||
| Netherlands | 2020-12-02 | 2020-12-02 | 2023-03-23 | ||
| Norway | 2022-04-19 | 2022-05-04 | 2023-03-24 | ||
| Spain | 2020-07-06 | 2020-07-10 | 2023-03-24 | ||
| Sweden | 2022-06-03 | 2022-08-26 | 2023-03-24 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Denmark | Acceptable 2024-04-03
|
2024-04-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-09 | Denmark | Acceptable 2024-04-03
|
2024-05-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-04 | Denmark | Acceptable 2024-04-03
|
2024-07-04 |