Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
42
Countries
2
Sites
10
Prostatic Neoplasms
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Jan 2024 → 21 Jan 2026
- Decision date (initial)
- 2023-12-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503919-15-00
- WHO UTN
- U1111-1294-1466
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostatic Neoplasms
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
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 4 |
| Spain | Ended | 26 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Urologie, Steinengrabenstrasse 17, 72622, Nuertingen
Klinikum rechts der Isar der TU Muenchen AöR
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Medical Center Hamburg-Eppendorf
Onkologisches Zentrum, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Schleswig-Holstein
Klinik für Urologie, Ratzeburger Allee 160, 23538, Lübeck
Hospital Universitario Infanta Cristina
Medical Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Germany | 2024-01-12 | 2024-01-16 | 2024-02-07 | ||
| Spain | 2024-01-09 | 2024-01-12 | 2024-02-07 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-14551
- Halt date
- 2024-02-07
- Member states concerned
- Germany
- Publication date
- 2024-02-21
- Reason
- Sponsor decision
- Follow-up measures
- The Sponsor has sent a letter to investigators requesting them to inform patients of the outcomes for the ongoing CYCLONE trials.
JPEI will enter the continued access phase and patients may continue on study treatment as per protocol, once investigator deems there is a clinical benefit.
Lilly will submit an early termination notification and CSR synopsis will be summitted upon local and global end of trial - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-14552
- Halt date
- 2024-02-07
- Member states concerned
- Spain
- Publication date
- 2024-02-21
- Reason
- Sponsor decision
- Follow-up measures
- The Sponsor has sent a letter to investigators requesting them to inform patients of the outcomes for the ongoing CYCLONE trials.
JPEI will enter the continued access phase and patients may continue on study treatment as per protocol, once investigator deems there is a clinical benefit.
Lilly will submit an early termination notification and CSR synopsis will be summitted upon local and global end of trial - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | Germany | Acceptable 2023-11-30
|
2023-11-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-29 | Germany | Acceptable 2023-11-30
|
2024-01-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-21 | Germany | Acceptable 2026-02-09
|
2026-02-10 |