Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
1
Countries
1
Sites
1
Lung Cancer or 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
- 15 Nov 2016 → ongoing
- Decision date (initial)
- 2024-03-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506788-32-00
- EudraCT number
- 2015-005156-94
- WHO UTN
- U1111-1296-4617
- ClinicalTrials.gov
- NCT02779751
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lung Cancer or 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | 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 |
|---|---|---|---|---|---|
| Belgium | 2016-11-15 | 2017-02-22 | 2019-08-19 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Belgium | Acceptable 2024-03-04
|
2024-03-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-16 | Belgium | Acceptable 2024-08-12
|
2024-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-07 | Belgium | Acceptable | 2024-11-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-30 | Belgium | Acceptable 2025-02-14
|
2025-02-14 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | Belgium | Acceptable 2025-02-14
|
2025-12-19 |