Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
147
Countries
2
Sites
5
Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Sep 2021 → 19 May 2026
- Decision date (initial)
- 2023-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505340-19-00
- EudraCT number
- 2021-001569-18
- WHO UTN
- U1111-1291-5232
- ClinicalTrials.gov
- NCT05017012
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Omobolaji Akala
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Omobolaji Akala
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 15 | 2 |
| Spain | Ended | 19 | 3 |
| Rest of world
Chile, Korea, Republic of, Japan, South Africa
|
— | 113 | — |
Investigational sites
Orszagos Onkologiai Intezet
Gyógyszerterápiás Központ, Urogenitális Tumorok és Klinikai Farmakológiai Osztály ,,Kemoterápia C”, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Central Hospital Of Northern Pest Military Hospital
Onkológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 |
|---|---|---|---|---|---|
| Hungary | 2021-11-22 | 2024-04-17 | 2021-11-26 | 2024-02-16 | |
| Spain | 2021-09-20 | 2024-09-19 | 2021-09-21 | 2024-02-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | m5332-pc18v01mk3475a-csr-body | 1 |
| Clinical study report (for publication) | m5332-pc18v01mk3475a-s-app1611-protocol | 1 |
| Clinical study report (for publication) | m5332-pc18v01mk3475a-s-app1612-crf | 1 |
| Clinical study report (for publication) | m5332-pc18v01mk3475a-s-app1619-sap | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-03 | Spain | Acceptable 2023-10-11
|
2023-10-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-16 | Spain | Acceptable 2023-10-11
|
2023-11-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-21 | Spain | Acceptable | 2023-12-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-04 | Spain | Acceptable 2024-02-08
|
2024-02-19 |