Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
61
Countries
3
Sites
12
Breast Cancer
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Sep 2020 → ongoing
- Decision date (initial)
- 2024-04-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506785-32-00
- EudraCT number
- 2019-003581-41
- WHO UTN
- U1111-1300-7197
- ClinicalTrials.gov
- NCT04188548
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Breast Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 2 | 3 |
| France | Ongoing, recruitment ended | 3 | 3 |
| Spain | Ongoing, recruitment ended | 7 | 6 |
| Rest of world
Taiwan, Japan, Korea, Republic of, Australia, United States
|
— | 49 | — |
Investigational sites
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Jules Bordet
Clinical Trial Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Gynecologic Oncology, Herestraat 49, 3000, Leuven
Institut Curie
Oncology medical Department, 26 Rue D Ulm, 75005, Paris
Institut De Cancerologie De L Ouest
Oncologie Médicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut De Cancerologie Strasbourg Europe
NA, 17 Rue Albert Calmette, 67200, Strasbourg
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Clinic De Barcelona
Haematological and Oncological diseases, Calle Villarroel 170, 08036, 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 |
|---|---|---|---|---|---|
| Belgium | 2021-01-05 | 2021-01-18 | 2022-12-19 | ||
| France | 2021-09-21 | 2021-10-01 | 2023-02-09 | ||
| Spain | 2020-09-11 | 2020-09-23 | 2023-02-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | LY3484356 J2J-MC-JZLA 04 CSR synopsis and body_Redacted | 2 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Spain | Acceptable 2024-04-26
|
2024-04-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-13 | Spain | Acceptable 2024-07-25
|
2024-07-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-21 | Spain | Acceptable 2025-04-29
|
2025-04-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-26 | Acceptable | 2025-11-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-30 | Spain | Acceptable | 2025-10-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-30 | Acceptable | 2025-10-29 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-16 | Spain | Acceptable 2026-02-23
|
2026-02-23 |