Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
392
Countries
6
Sites
9
Small Cell Lung Cancer
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Aug 2018 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506541-39-00
- EudraCT number
- 2017-003421-15
- WHO UTN
- U1111-1305-1420
- ClinicalTrials.gov
- NCT03319940
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
6 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 1 |
| France | Ongoing, recruitment ended | 23 | 1 |
| Germany | Ongoing, recruitment ended | 11 | 1 |
| Netherlands | Ended | 10 | 1 |
| Poland | Ongoing, recruitment ended | 5 | 2 |
| Spain | Ongoing, recruitment ended | 65 | 3 |
| Rest of world
United Kingdom, China, Japan, Switzerland, Australia, United States, Taiwan
|
— | 274 | — |
Investigational sites
Institut Gustave Roussy
Service des Innovations Therapeutiques et Essais precoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Wuerzburg AöR
Comprehensive Cancer Center Mainfranken (CCCM), Straubmuehlweg 2a, Grombuehl, Wuerzburg
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
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 |
|---|---|---|---|---|---|
| Austria | 2021-10-25 | 2026-04-28 | 2022-03-04 | 2024-04-18 | |
| France | 2018-08-03 | 2018-11-12 | 2024-04-18 | ||
| Germany | 2018-10-26 | 2018-12-05 | 2024-04-18 | ||
| Netherlands | 2019-05-28 | 2024-12-06 | 2019-08-03 | 2024-04-18 | |
| Poland | 2022-04-08 | 2022-06-27 | 2024-04-18 | ||
| Spain | 2019-02-08 | 2019-06-25 | 2024-04-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | Interim Analysis CSR_Protocol_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Report Body_2023-506541-39_Part 1_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Report Body_2023-506541-39_Part 2_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Report Body_2023-506541-39_Part 3_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Report Body_2023-506541-39_Part 4_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Sample CRF_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_SAP_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Interim Analysis CSR_Synopsis_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Protocol_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 1_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 2_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 3_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 4_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 5_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Report Body_2023-506541-39_Part 6_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_SAP_2023-506541-39_For Public | 1 |
| Clinical study report (for publication) | Primary Analysis Suppl CSR_Synopsis_2023-506541-39_For Public | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-06 | Austria | Acceptable with conditions 2024-07-17
|
2024-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Austria | Acceptable 2025-01-21
|
2025-01-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-07 | Austria | Acceptable 2025-05-13
|
2025-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-14 | Austria | Acceptable 2025-10-20
|
2025-10-22 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-18 | Austria | Acceptable 2026-01-19
|
2026-01-19 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-01 | Austria | Acceptable 2026-05-18
|
2026-05-21 |