Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
503
Countries
4
Sites
27
Participants with BRAF and/or NRAS mutation positive tumors
Key facts
- Sponsor
- Pierre Fabre Medicament
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Jun 2022 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516331-27-00
- EudraCT number
- 2021-005389-16
- ClinicalTrials.gov
- NCT04913285
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with BRAF and/or NRAS mutation positive tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pierre Fabre Medicament
- Sponsor organisation
- Pierre Fabre Medicament
- Address
- Les Cauquillous
- City
- Lavaur
- Postcode
- 81500
- Country
- France
Scientific contact point
- Organisation
- Pierre Fabre Medicament
- Contact name
- Corporate Scientific and Medical
Public contact point
- Organisation
- Pierre Fabre Medicament
- Contact name
- Corporate Scientific and Medical
Locations
4 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 106 | 12 |
| Germany | Authorised, recruitment pending | 18 | 3 |
| Italy | Ongoing, recruiting | 12 | 2 |
| Spain | Ongoing, recruiting | 46 | 10 |
| Rest of world
Australia, China, United States, Switzerland, Taiwan
|
— | 321 | — |
Investigational sites
Oncopole Claudius Regaud
Oncology Department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Poitiers
Oncology Department, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Oncology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Nice
Oncology, 151 Route De Saint Antoine, 06200, Nice
Centre Francois Baclesse
Oncology Department, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
Oncology Department, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional De Marseille
Oncology Department, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Lille
Oncology Department, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire De Nantes
Medical Oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Elbe Kliniken Stade-Buxtehude gGmbH
Dermatology, Am Krankenhaus 1, 21614, Buxtehude
University Medical Center Hamburg-Eppendorf
Dermatology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Essen AöR
Dermatology, Hufelandstrasse 55, Holsterhausen, Essen
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Medical Oncology, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology, Via Giacomo Venezian 1, 20133, Milan
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Oncology Department, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital General Universitario De Valencia
Oncology Department, Avenida Del Tres Cruces 2, 46014, Valencia
Complejo Hospitalario Universitario Insular Materno Infantil
Medical Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Clinic De Barcelona
Oncology Department, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Regional De Malaga
Oncology Department, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitari Dexeus Grupo Quironsalud
Oncology Department, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology Department, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Quironsalud Madrid
Oncology Department, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| France | 2022-06-22 | 2022-08-09 | |||
| Italy | 2025-10-10 | 2025-10-22 | |||
| Spain | 2022-06-10 | 2022-06-20 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Spain | Acceptable 2024-10-15
|
2024-10-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-02 | Spain | Acceptable 2025-01-21
|
2025-01-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-17 | Spain | Acceptable | 2025-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-17 | Acceptable | 2025-04-22 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-04-11 | Acceptable 2025-01-21
|
2025-06-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-23 | Spain | Acceptable 2025-09-17
|
2025-09-18 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-10-22 | Acceptable 2025-09-17
|
2025-12-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-18 | Spain | Acceptable | 2026-04-08 |