Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
2,442
Countries
1
Sites
21
Patients with Advanced Solid Tumors
Key facts
- Sponsor
- Tesaro Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Mar 2019 → ongoing
- Decision date (initial)
- 2024-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507564-39-00
- EudraCT number
- 2018-002143-29
- ClinicalTrials.gov
- NCT02817633
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with Advanced Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tesaro Inc.
- Sponsor organisation
- Tesaro Inc.
- Address
- 1000 Winter Street Suite 3300
- City
- Waltham
- Postcode
- 02451-1230
- Country
- United States
Scientific contact point
- Organisation
- Tesaro Inc.
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Tesaro Inc.
- Contact name
- Clinical Trial Mailbox
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 1,221 | 21 |
| Rest of world
United States, Korea, Republic of
|
— | 1,221 | — |
Investigational sites
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Clinico Universitario Lozano Blesa
Digestive, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitari De Girona Doctor Josep Trueta
Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Micancer Center S.L.P.
Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Hematology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
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 |
|---|---|---|---|---|---|
| Spain | 2019-03-11 | 2019-03-15 | 2025-09-05 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Spain | Acceptable 2024-01-30
|
2024-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-27 | Spain | Acceptable 2024-07-19
|
2024-07-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-25 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-14 | Spain | Acceptable 2025-03-27
|
2025-04-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-27 | Spain | Acceptable 2025-11-28
|
2025-12-19 |