Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
1,106
Countries
6
Sites
15
Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation
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
- 1 Apr 2022 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506794-35-00
- EudraCT number
- 2020-004721-23
- WHO UTN
- U1111-1310-9389
- ClinicalTrials.gov
- NCT04185883
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 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 · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 5 | 1 |
| Belgium | Ongoing, recruitment ended | 23 | 2 |
| Germany | Ongoing, recruitment ended | 4 | 2 |
| Italy | Ongoing, recruitment ended | 19 | 3 |
| Netherlands | Ongoing, recruitment ended | 5 | 1 |
| Spain | Ongoing, recruitment ended | 80 | 6 |
| Rest of world
Japan, Canada, Australia, United States, Taiwan, United Kingdom, Korea, Republic of
|
— | 970 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
Department of Internal Medicine IIII, Muellner Hauptstrasse 48, 5020, Salzburg
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
University Hospital Cologne AöR
Centre for Integrated Oncology, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Essen AöR
Department of Internal Medicine (Tumour Research), Hufelandstrasse 55, Holsterhausen, Essen
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Ematologia Oncologia e Medicina molecolare, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Clinical Pharmacology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero Universitaria Pisana
Ospedale Santa Chiara Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci, Via Roma 67, 56126, Pisa
Universitair Medisch Centrum Utrecht
Medical oncology, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Oncología Médica, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinic De Barcelona
Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Austria | 2022-05-31 | 2025-11-26 | 2022-07-05 | 2025-02-24 | |
| Belgium | 2022-04-28 | 2022-05-10 | 2025-02-24 | ||
| Germany | 2022-07-04 | 2022-09-08 | 2023-10-04 | ||
| Italy | 2022-09-06 | 2022-10-25 | 2025-02-24 | ||
| Netherlands | 2022-12-23 | 2023-02-09 | 2025-02-24 | ||
| Spain | 2022-04-01 | 2022-04-12 | 2025-02-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Protocol_2023-506794-35_For Publication | 1 |
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Report_2023-506794-35_For Publication | 1 |
| Clinical study report (for publication) | CSR_Synopsis Interim Analysis Synopsis_2023-506794-35_For Publication | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Belgium | Acceptable with conditions 2024-09-09
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-08 | Acceptable with conditions | 2024-12-27 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Acceptable with conditions | 2025-02-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-16 | Belgium | Acceptable 2025-07-16
|
2025-07-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-30 | Belgium | Acceptable 2026-01-08
|
2026-01-09 |