Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
945
Countries
6
Sites
42
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
- 19 Apr 2017 → ongoing
- Decision date (initial)
- 2024-03-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506390-35-00
- EudraCT number
- 2016-000320-26
- ClinicalTrials.gov
- NCT02715284
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
- Tesaro, Inc
Public contact point
- Organisation
- Tesaro Inc.
- Contact name
- Tesaro, Inc
Locations
6 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 5 | 1 |
| Denmark | Ongoing, recruitment ended | 7 | 1 |
| France | Ongoing, recruitment ended | 129 | 9 |
| Italy | Ongoing, recruitment ended | 55 | 5 |
| Poland | Ongoing, recruitment ended | 130 | 4 |
| Spain | Ongoing, recruitment ended | 194 | 22 |
| Rest of world
Argentina, Mexico, United States, Brazil, Korea, Republic of, United Kingdom, Canada
|
— | 425 | — |
Investigational sites
Krajska Nemocnice T Bati a.s.
Komplexní onkologické centrum (Comprehensive Oncology Center), Havlickovo Nabrezi 600, 760 01, Zlin
Rigshospitalet
Dept. of Oncology 5073, Blegdamsvej 9, 2100, Copenhagen Oe
Assistance Publique Hopitaux De Paris
Service d’Oncologie Médicale, 20 Rue Leblanc, 75015, Paris
Centre Francois Baclesse
Département de Médecine Oncologique, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Oscar Lambret
Département de Cancérologie Gynécologie, 3 Rue Frederic Combemale, 59000, Lille
Hopital Saint Antoine
Service d’Oncologie médicale, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Lyon Sud
Département d’Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Bergonie
Départment D'Oncologie Médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Département d’Innovation Thérapeutique et des Essais Précoses, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Service d'Oncologie Médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
Département d’Oncologie médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Di Modena
Struttura complessa di Oncologia, Largo Del Pozzo 71, 41124, Modena
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Ospedale San Raffaele S.r.l.
Dipartimento di Oncologia Medica Settore Q - 1° piano, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii i Radioterapii, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.
Chemotherapy Clinic, Ul. Mikolaja Kopernika 30, 10-513, Olsztyn
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Oddział Chemioterapii Nowotworów, Ul. Sw. Jozefa 53/59, 87-100, Torun
Hospital De La Santa Creu I Sant Pau
Medical Oncology Department, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario La Paz
Oncology Service Department, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology Department, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Oncology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Reina Sofia
Oncology Department, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Hm Sanchinarro
Oncology Department, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology Department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Marques De Valdecilla
Oncology Department, Avenida Valdecilla Sn, 39008, Santander
Complexo Hospitalario Universitario De Santiago
Medical Oncology Department, Calle Choupana Da S/n, 15706, Santiago De Compostela
University Hospital Virgen Del Rocio S.L.
Oncology Department, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
Medical Oncology Department, Calle Villarroel 170, 08036, Barcelona
Fundacion Instituto Valenciano De Oncologia
Oncology Department, Calle Professor Beltran Baguena 8, 46009, Valencia
Clinica Universidad De Navarra
Oncology Department, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario De Jaen
Medical Oncology Department, Avenida Del Ejercito Espanol 10, 23007, Jaen
Institut Catala D'oncologia
Oncology Service Department, Avinguda De Franca S/n, 17007, Girona
Hospital Clinico San Carlos
Oncology Department, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncology Department, Carretera De Cartagena Sn, El Palmar, Murcia
Clinica Universidad De Navarra
Oncology Department, Avenue Pio XII 36, 31008, Pamplona
Hospital Unviersitario Miguel Servet
Medical Oncology Department, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology Department, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Clinico Universitario De Valencia
Oncology Service Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology Department, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Czechia | 2017-06-28 | 2017-10-30 | 2025-05-09 | ||
| Denmark | 2017-05-30 | 2018-01-26 | 2025-05-09 | ||
| France | 2017-08-24 | 2017-11-23 | 2025-05-09 | ||
| Italy | 2017-07-04 | 2018-03-08 | 2025-05-09 | ||
| Poland | 2017-10-13 | 2018-03-26 | 2025-05-09 | ||
| Spain | 2017-04-19 | 2017-06-13 | 2025-05-09 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-12 | Denmark | Acceptable 2024-03-15
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-26 | Acceptable | 2024-09-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-14 | Acceptable | 2024-10-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-12 | Denmark | Acceptable 2025-02-25
|
2025-02-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-28 | Denmark | Acceptable 2026-02-16
|
2026-02-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-04 | Acceptable | 2026-03-16 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-29 | Acceptable | 2026-05-29 |