Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
425
Countries
5
Sites
19
Advanced solid tumours
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Jun 2019 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509605-77-00
- EudraCT number
- 2018-003075-35
- ClinicalTrials.gov
- NCT03530397
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumours
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Trial Enquiries
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Trial Enquiries
Locations
5 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 25 | 3 |
| Italy | Ongoing, recruitment ended | 20 | 3 |
| Netherlands | Ended | 10 | 1 |
| Portugal | Ended | 20 | 2 |
| Spain | Ongoing, recruitment ended | 130 | 10 |
| Rest of world
Korea, Republic of, Taiwan, Australia, United States
|
— | 220 | — |
Investigational sites
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Cancer Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Medical oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Azienda Unita Sanitaria Locale Della Romagna
Ospedale S. Maria delle Croci, Dipartimento di Oncoematologia Viale Vincenzo Randi 5, Ravenna, 48121, Via Alcide De Gasperi 8, 48121, Ravenna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Dipartimento Oncologia ed Ematologia Clinica e Sperimentale, Via Piero Maroncelli 40, 47014, Meldola
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Dipartimento Ematologia e Terapie Innovative, Via Mariano Semmola 52, 80131, Naples
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical oncology and clinical pharmacology, Plesmanlaan 121, 1066 CX, Amsterdam
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Institut Catala D'oncologia
Medical Oncology Department, Carretera Canyet S/n, 08916, Badalona
Hospital De La Santa Creu I Sant Pau
Medical Oncology Department, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Medical Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Del Mar
Medical Oncology Department, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario A Coruna
Medical Oncology Department, Lugar Jubias De Arriba 84, 15006, A Coruna
Clinica Universidad De Navarra
Medical Oncology Department, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology Department, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology Department, Calle De Manuel De Falla 1, 28222, Majadahonda
Instituto Oncologico Dr. Rosell S.L.
Medical Oncology Department, Calle De Sabino Arana Num. 5, 08028, Barcelona
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 | 2020-06-12 | 2025-07-14 | 2020-07-02 | 2023-12-28 | |
| Italy | 2019-09-05 | 2019-11-18 | 2023-12-28 | ||
| Netherlands | 2020-08-26 | 2025-07-14 | 2022-03-03 | 2023-12-28 | |
| Portugal | 2020-05-20 | 2025-07-14 | 2020-05-28 | 2023-12-28 | |
| Spain | 2019-06-27 | 2019-08-12 | 2023-12-07 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | Spain | Acceptable with conditions 2024-08-06
|
2024-08-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-25 | Spain | Acceptable 2025-02-04
|
2025-02-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-26 | Spain | Acceptable 2025-06-30
|
2025-06-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-16 | Spain | Acceptable 2025-11-17
|
2025-11-19 |