Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
222
Countries
5
Sites
27
Pancreatic Ductal Adenocarcinoma
Key facts
- Sponsor
- Revolution Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2022 → ongoing
- Decision date (initial)
- 2024-04-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511548-19-00
- EudraCT number
- 2022-000388-35
- ClinicalTrials.gov
- NCT05462717
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic Ductal Adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Revolution Medicines Inc.
- Sponsor organisation
- Revolution Medicines Inc.
- Address
- 700 Saginaw Drive
- City
- Redwood City
- Postcode
- 94063-4752
- Country
- United States
Scientific contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Responsible Medical Monitor
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Responsible Medical Monitor
Locations
5 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 5 | 3 |
| France | Ongoing, recruitment ended | 45 | 7 |
| Italy | Ongoing, recruitment ended | 16 | 6 |
| Poland | Ongoing, recruitment ended | 8 | 3 |
| Spain | Ongoing, recruitment ended | 30 | 8 |
| Rest of world
Taiwan, United States, Korea, Republic of, Australia, Malaysia, Singapore, Serbia, Thailand
|
— | 118 | — |
Investigational sites
Fakultni Nemocnice Hradec Kralove
Department of Oncology and Radiotherapy, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
Department of Oncology, Zdravotniku 248/7, 779 00, Olomouc
Multiscan s.r.o.
Oncological Care Center, K Nemocnici 1106, 268 31, Horovice
Centre Hospitalier Universitaire De Nantes
Oncology medical department – Oncology thoracic unit, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
CHU De Bordeauxt
Medical Oncology department, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Leon Berard
Medical Oncology department, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
Oncology department, 15 Rue Andre Boquel, 49100, Angers
Centre Jean Perrin
Medical Oncology department, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
Les Hopitaux Universitaires De Strasbourg
Medical Oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
European Institute Of Oncology S.r.l.
Division of New Drug Development for Innovative Therapies, Via Giuseppe Ripamonti 435, 20141, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Research Center Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Experimental Clinical Oncology Melanoma Immunotherapy and Innovative Therapies, Via Mariano Semmola 52, 80131, Naples
ASST Grande Ospedale Metropolitano Niguarda
Hematology and Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Policlinico San Matteo
Medical Sciences and Infectious Disease Dep., Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Medical Oncology, Regione Gonzole 10, 10043, Orbassano
Med Polonia Sp. z o.o.
Oncology, Obornicka 262, 60-693, Poznan
Instytut Msf Sp. z o.o.
Department of Oncology, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Early Phase Clinical Trials Unit and Department of Soft Tissue/Bone Sarcoma and Melanoma, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
MD Anderson Cancer Center
Medical oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Miguel Servet
Oncology service, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
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 |
|---|---|---|---|---|---|
| Czechia | 2023-10-19 | 2023-11-09 | 2024-02-29 | ||
| France | 2023-01-20 | 2023-02-13 | 2024-06-05 | ||
| Italy | 2023-07-05 | 2023-07-19 | 2024-06-04 | ||
| Poland | 2022-12-13 | 2023-04-04 | 2024-05-07 | ||
| Spain | 2023-05-09 | 2023-06-19 | 2024-05-23 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-20 | Spain | Acceptable 2024-04-01
|
2024-04-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-08 | Spain | Acceptable 2024-09-24
|
2024-09-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Spain | Acceptable 2025-02-11
|
2025-02-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-16 | Acceptable | 2025-10-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-21 | Spain | Acceptable 2026-02-26
|
2026-03-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-03 | Acceptable 2026-06-02
|
2026-06-02 |