Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
1,492
Countries
2
Sites
7
Bladder cancer and kidney cancer
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
- 7 Mar 2018 → ongoing
- Decision date (initial)
- 2024-09-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516477-73-00
- EudraCT number
- 2017-001792-24
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Bladder cancer and kidney cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
| 27.0 | PT | 10014734 | Endometrial cancer metastatic | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | LLT | 10036707 | Primary liver cancer recurrent | 10029104 |
| 21.1 | LLT | 10043738 | Thyroid gland cancer | 10029104 |
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 27.0 | PT | 10071540 | Head and neck cancer metastatic | 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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 160 | 1 |
| Spain | Ongoing, recruitment ended | 160 | 6 |
| Rest of world
Australia, United States, United Kingdom
|
— | 1,172 | — |
Investigational sites
Institut Gustave Roussy
Départment D'Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
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 | 2018-03-07 | 2025-01-14 | 2018-05-11 | 2022-01-06 | |
| Spain | 2018-04-05 | 2018-04-06 | 2022-01-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Spain | Acceptable with conditions 2024-09-16
|
2024-09-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-09 | Spain | Acceptable 2025-05-23
|
2025-05-23 |