Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
1
small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), follicular lymphoma (FL)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Jul 2024 → 12 Nov 2024
- Decision date (initial)
- 2024-05-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), follicular lymphoma (FL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 24.0 | PT | 10085128 | Follicular lymphoma | 100000004864 |
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-07-15 | 2024-11-11 | 2024-07-18 | 2024-09-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-02 | Netherlands | Acceptable 2024-05-28
|
2024-05-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-03 | Netherlands | Acceptable 2024-05-28
|
2024-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-25 | Netherlands | Acceptable 2024-07-08
|
2024-07-08 |