Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
1
Countries
1
Sites
1
Metastatic 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
- 21 Nov 2016 → ongoing
- Decision date (initial)
- 2024-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507177-17-00
- EudraCT number
- 2016-001431-12
- WHO UTN
- U1111-1303-4449
- ClinicalTrials.gov
- NCT02937272
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2016-11-21 | 2016-11-28 | 2019-10-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-16 | Spain | Acceptable 2024-02-27
|
2024-02-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-10 | Spain | Acceptable | 2024-04-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-17 | Spain | Acceptable 2024-11-15
|
2024-11-15 |