Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
164
Countries
5
Sites
10
Melanoma: Adjuvant treatment of patients with Stage IIB, IIC, or III melanoma following complete resection
Key facts
- Sponsor
- Formycon AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 21 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Melanoma: Adjuvant treatment of patients with Stage IIB, IIC, or III melanoma following complete resection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10066600 | Melanoma recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Formycon AG
- Sponsor organisation
- Formycon AG
- Address
- Fraunhoferstrasse 15, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- Formycon AG
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Formycon AG
- Contact name
- Clinical Trial Information Desk
Locations
5 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 8 | 2 |
| Estonia | Ongoing, recruitment ended | 20 | 1 |
| Lithuania | Ongoing, recruitment ended | 20 | 1 |
| Poland | Ongoing, recruitment ended | 17 | 2 |
| Romania | Ongoing, recruitment ended | 51 | 4 |
| Rest of world
Serbia, Bosnia and Herzegovina, Georgia, Ukraine, North Macedonia, Moldova, Republic of
|
— | 48 | — |
Investigational sites
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Medical Oncology Clinic, Oborishte Distr., Ul.Byalo More 8, Sofia
Multiprofile Hospital for Active Treatment Sveta Sofia
Department of Medical Oncology, Bulevard Bilgariya 104, 1404, Sofiya
Tartu University Hospital
N/A, A006, L. Puusepa Tn 8, Tartu Linn
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
N/A, Eiveniu G. 2, Kauno M. Sav., Kaunas
Krakowskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow
Ip Clinic Sp. z o.o.
N/A, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Arensia Exploratory Medicine S.R.L.
Medical Oncology, Strada Banul Antonache 40-44 4th Floor District 1, Sector 1, Bucharest
Arensia Clinics S.R.L.
Oncology, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Arensia Exploratory Medicine S.R.L.
Medical Oncology, Strada Banul Antonache 40-44 4th Floor District 1, Sector 1, Bucharest
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-10-21 | 2024-12-10 | 2025-07-09 | ||
| Estonia | 2024-12-11 | 2025-02-06 | 2025-07-09 | ||
| Lithuania | 2025-02-03 | 2025-02-28 | 2025-07-09 | ||
| Poland | 2025-02-07 | 2025-03-31 | 2025-07-09 | ||
| Romania | 2024-12-10 | 2024-12-12 | 2025-07-09 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-03 | Poland | Acceptable 2024-08-26
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-23 | Poland | Acceptable | 2024-11-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-23 | Acceptable | 2024-11-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-23 | Acceptable | 2024-12-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-23 | Acceptable | 2024-11-11 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-09-24 | Acceptable 2024-08-26
|
2024-11-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-20 | Acceptable | 2025-02-03 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-31 | Poland | Acceptable | 2025-03-13 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-22 | Poland | Acceptable 2025-12-11
|
2025-12-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-13 | Acceptable 2025-12-11
|
2026-02-13 |