Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
146
Countries
8
Sites
24
Gastrointestinal tract, biliary tract, or pancreatic cancers with homozygous methylthioadenosine phosphorylase (MTAP)-deletion
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511195-33-00
- WHO UTN
- U1111-1303-8229
- ClinicalTrials.gov
- NCT06360354
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Gastrointestinal tract, biliary tract, or pancreatic cancers with homozygous methylthioadenosine phosphorylase (MTAP)-deletion
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10055111 | Biliary cancer metastatic | 100000004864 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 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
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
8 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 3 |
| Denmark | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 5 | 4 |
| Germany | Ended | 19 | 3 |
| Greece | Ongoing, recruitment ended | 5 | 4 |
| Italy | Ongoing, recruitment ended | 15 | 4 |
| Netherlands | Ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 9 | 3 |
| Rest of world
Australia, Canada, Japan, Taiwan, United States, United Kingdom, Korea, Republic of, Hong Kong
|
— | 65 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Paoli Calmettes
Outpatient Hospital, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut Gustave Roussy
DITEP Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Universitaetsklinikum Heidelberg AöR
Nationales Centrum fuer Tumorerkrankungen, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Wuerzburg AöR
Comprehensive Cancer Center – Mainfranken, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Essen AöR
Innere Klinik - Tumorforschung, Hufelandstrasse 55, Holsterhausen, Essen
General Hospital Of Thessaloniki Papageorgiou
Molecular Medicine Clinic/Clinical Trial Unit, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Alexandra Hospital
Oncology Department / Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
Humanitas Mirasole S.p.A.
Oncologia Medica, Via Alessandro Manzoni 56, 20089, Rozzano
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Medica, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Oncologia Medica, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Amsterdam UMC Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Radboud universitair medisch centrum
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Servicio de Oncologia Medica, Calle Del Doctor Esquerdo 46, 28009, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Belgium | 2024-10-16 | 2024-11-07 | 2026-04-30 | ||
| Denmark | 2024-10-23 | 2024-11-06 | 2026-04-30 | ||
| France | 2024-10-31 | 2024-11-07 | 2026-04-30 | ||
| Germany | 2024-09-30 | 2024-10-16 | 2026-04-30 | ||
| Greece | 2024-09-23 | 2024-09-23 | 2026-04-30 | ||
| Italy | 2024-10-30 | 2024-11-25 | 2026-04-30 | ||
| Netherlands | 2024-10-29 | 2024-11-07 | 2026-04-30 | ||
| Spain | 2024-10-15 | 2024-10-16 | 2026-04-30 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-07 | Denmark | Acceptable 2024-08-27
|
2024-08-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-09 | Acceptable 2024-08-27
|
2024-09-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-19 | Denmark | Acceptable 2025-06-04
|
2025-06-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-04 | Acceptable 2025-06-04
|
2025-07-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-28 | Denmark | Acceptable 2025-11-03
|
2025-11-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-11 | Acceptable | 2025-11-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-12 | Acceptable | 2025-12-18 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-01-23 | Acceptable | 2026-01-23 |