Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
66
Countries
2
Sites
8
extensive stage small cell lung cancer
Key facts
- Sponsor
- Celgene Corp., Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Feb 2019 → 17 Jul 2024
- Decision date (initial)
- 2024-02-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509800-14-00
- EudraCT number
- 2018-002799-42
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
extensive stage small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 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
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 23 | 1 |
| Spain | Ended | 43 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Clinica di Oncologia Medica, Via Filippo Corridoni 11, 60123, Ancona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Joaquin Dicenta 2, 28029, Madrid
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Italy | 2019-05-16 | 2019-07-26 | 2021-11-09 | ||
| Spain | 2019-02-25 | 2019-03-12 | 2022-06-20 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Spain | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-13 | Spain | Acceptable 2024-01-15
|
2024-03-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-01 | Spain | Acceptable 2024-01-15
|
2024-05-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-14 | Spain | Acceptable | 2024-05-30 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-10 | Acceptable |