Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
270
Countries
3
Sites
26
Castration Resistant Prostate Cancer (CRPC)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Aug 2019 → ongoing
- Decision date (initial)
- 2024-09-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509179-18-00
- EudraCT number
- 2018-001835-37
- ClinicalTrials.gov
- NCT03460977
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Castration Resistant Prostate Cancer (CRPC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10080213 | In situ follicular lymphoma | 10029104 |
| 21.0 | LLT | 10012820 | Diffuse large B-cell lymphoma NOS | 10029104 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 21.1 | LLT | 10041071 | Small cell lung cancer stage unspecified | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
3 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 4 | 4 |
| Poland | Ongoing, recruiting | 12 | 6 |
| Spain | Ongoing, recruiting | 90 | 16 |
| Rest of world
Russian Federation, China, Japan, Korea, Republic of, United States
|
— | 164 | — |
Investigational sites
Complex Oncology Center Vratsa EOOD
Department of Medical Oncology, Bulevard Vtori Yuni 68, 3000, Vratsa
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department of Medical Oncology, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncological Center Plovdiv EOOD
Department of Medical Oncology and Oncological Diseases in Gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Complex Oncology Center Ruse EOOD
Department of Medical Oncology, 2 Nezavisimost street, 7000, Ruse
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
N/A, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
N/A, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Lux Med Onkologia Sp. z o.o.
N/A, Ul. Szamocka 6, 01-748, Warsaw
Centrum Medyczne Medyk Sp. z o.o.
N/A, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Jagiellonskie Centrum Innowacji Sp. z o.o.
N/A, Ul. Profesora Michala Bobrzynskiego 14, 30-348, Cracow
In Vivo Sp. z o.o.
N/A, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Hospital De La Santa Creu I Sant Pau
Hematology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
N/A, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
N/A, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
Hospital Hm Nou Delfos
N/A, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
N/A, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
N/A, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Hm Sanchinarro
N/A, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Institut Catala D'oncologia
N/A, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Consorcio Hospitalario Provincial De Castellon
N/A, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario Ramon Y Cajal
N/A, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Virgen De La Victoria
N/A, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Clinico Universitario De Valencia
Hematology and Medical Oncology Service, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Clinico San Carlos
Oncology Service, Calle Del Profesor Martin Lagos Sn, 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 |
|---|---|---|---|---|---|
| Bulgaria | 2023-07-20 | 2024-07-04 | 2024-06-27 | ||
| Poland | 2023-05-16 | 2023-05-16 | |||
| Spain | 2019-08-13 | 2019-10-08 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Spain | Acceptable with conditions 2024-08-28
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-23 | Spain | Acceptable with conditions | 2024-11-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | Spain | Acceptable 2025-06-09
|
2025-06-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Spain | Acceptable 2025-09-01
|
2025-09-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-09 | Spain | Acceptable | 2025-10-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-19 | Spain | Acceptable 2026-02-19
|
2026-02-22 |