Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
320
Countries
5
Sites
24
Advanced clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), colorectal cancer (CRC)
Key facts
- Sponsor
- Exelixis Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Feb 2022 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515617-18-00
- EudraCT number
- 2020-003569-21
- ClinicalTrials.gov
- NCT03845166
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), colorectal cancer (CRC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10073251 | Clear cell renal cell carcinoma | 100000004864 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 20.1 | LLT | 10080007 | Clear cell renal cell carcinoma metastatic | 10029104 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Exelixis Inc.
- Sponsor organisation
- Exelixis Inc.
- Address
- 1851 Harbor Bay Parkway
- City
- Alameda
- Postcode
- 94502-3010
- Country
- United States
Scientific contact point
- Organisation
- Exelixis Inc.
- Contact name
- Exelixis, Inc.
Public contact point
- Organisation
- Exelixis Inc.
- Contact name
- Exelixis, Inc.
Locations
5 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 3 |
| Czechia | Ongoing, recruitment ended | 4 | 1 |
| France | Ongoing, recruitment ended | 57 | 9 |
| Germany | Ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 63 | 9 |
| Rest of world
United States, Australia, United Kingdom
|
— | 180 | — |
Investigational sites
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
Medical Oncology, 20 Rue Leblanc, 75015, Paris
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Jean Perrin
Medical Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Francois Baclesse
Medical Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Klinikum rechts der Isar der TU Muenchen AöR
Urological Oncology, Ismaninger Strasse 22, Au-Haidhausen, Munich
Haematologisch Onkologische Praxis Eppendorf
Oncology, Eppendorfer Landstrasse 42, 20249, Hamburg
Parc Tauli Hospital Universitari
Medical Oncology, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Quironsalud Barcelona
Medical Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Del Mar
Medical Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, 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 | 2022-05-30 | 2024-08-19 | 2022-10-25 | 2023-03-31 | |
| Czechia | 2022-02-14 | 2022-04-25 | 2022-10-20 | ||
| France | 2022-02-16 | 2022-03-31 | 2023-06-12 | ||
| Germany | 2022-03-15 | 2026-01-27 | 2022-04-29 | 2023-03-04 | |
| Spain | 2022-02-22 | 2022-04-12 | 2023-06-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Germany | Acceptable 2024-09-10
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-03 | Germany | Acceptable 2025-05-30
|
2025-06-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-25 | Germany | Acceptable 2026-03-09
|
2026-03-10 |