Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
110
Countries
7
Sites
27
Advanced or metastatic solid tumors with a KRAS-G12C mutation
Key facts
- Sponsor
- Navire Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Mar 2023 → 22 Aug 2024
- Decision date (initial)
- 2023-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501363-40-00
- ClinicalTrials.gov
- NCT05480865
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic solid tumors with a KRAS-G12C mutation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028980 | Neoplasm | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Navire Pharma Inc.
- Sponsor organisation
- Navire Pharma Inc.
- Address
- 1800 Owens Street Floor 12th
- City
- San Francisco
- Postcode
- 94158-2388
- Country
- United States
Scientific contact point
- Organisation
- Navire Pharma Inc.
- Contact name
- David van Veenhuyzen
Public contact point
- Organisation
- Navire Pharma Inc.
- Contact name
- David van Veenhuyzen
Locations
7 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 7 | 2 |
| Denmark | Ended | 3 | 1 |
| France | Ended | 15 | 6 |
| Greece | Ended | 15 | 5 |
| Italy | Ended | 15 | 4 |
| Netherlands | Ended | 10 | 2 |
| Spain | Ended | 10 | 7 |
| Rest of world
Australia
|
— | 35 | — |
Investigational sites
Grand Hopital de Charleroi
Oncology, Grand Rue 3, 6000, Charleroi
CHU De Liege
Oncology, Avenue De L'hopital 1, 4000, Liege
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Centr Georges Francois Leclerc
Medical oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Bergonie
Medical oncology, 229 Cours De L Argonne, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Oncology department, 46 Rue Henri Huchard, 75877, Paris Cedex 18
St. Luke's Hospital S.A.
Department of Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
University General Hospital Of Heraklion
Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion
Athens Medical Center S.A. - The European Interbalkan Medical Center in Thessaloniki
Department of Medical Oncology, 10 Asklipiou Street, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine of University of Athens, Oncology Unit, Messogion Avenue 152, 115 27, Athens
University General Hospital Attikon
2nd Propaeudeutic Internal Medicine Clinic, Oncology Unit, Rimini Street 1, 124 62, Athens
Careggi University Hospital
SODc Medical Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria - Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Onco-hematology, Piazza Luigi Miraglia 2, 80138, Naples
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Unit of Melanoma, Cancer lmmunotherapy and Development, Via Mariano Semmola 52, 80131, Naples
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC medical oncology, Piazzale Spedali Civili 1, 25123, Brescia
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Thoraxoncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Netherlands Cancer Institute
Lung Cancer and Thoracic Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
University Clinic Of Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Denmark | 2023-11-09 | 2024-01-18 | 2024-04-09 | ||
| France | 2023-03-17 | 2023-03-28 | 2024-04-09 | ||
| Greece | 2023-11-28 | ||||
| Italy | 2023-08-11 | 2023-10-24 | 2024-04-09 | ||
| Netherlands | 2023-10-16 | 2023-11-21 | 2024-04-09 | ||
| Spain | 2023-05-04 | 2023-06-01 | 2024-04-09 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-02 | Spain | Acceptable 2023-01-09
|
2023-01-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-06 | Spain | Acceptable | 2023-03-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-02-14 | Acceptable | 2023-04-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-02-28 | Acceptable | 2023-04-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-02-28 | Acceptable | 2023-05-04 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2023-04-21 | Acceptable 2023-01-09
|
2023-07-18 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2023-04-21 | Acceptable 2023-01-09
|
2023-07-10 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2023-04-21 | Acceptable 2023-01-09
|
2023-07-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-06-13 | Acceptable | 2023-07-12 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-08-25 | Acceptable | 2023-10-17 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-24 | Spain | Acceptable | 2023-10-24 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-31 | Acceptable | ||
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-10-31 | Spain | 2023-10-31 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-02-24 | Spain | Acceptable 2024-04-08
|
2024-04-08 |