Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
340
Countries
2
Sites
9
Melanoma
Key facts
- Sponsor
- Intas Pharmaceuticals Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Jan 2026 → ongoing
- Decision date (initial)
- 2025-12-08
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Intas Pharmaceuticals Limited
- Sponsor organisation
- Intas Pharmaceuticals Limited
- Address
- Plot No 423/P/A Sarkhej-Bavla Highway, Village Moraiya, Taluka-Sanand Village Moraiya Taluka-Sanand
- City
- Ahmedabad
- Postcode
- 382213
- Country
- India
Scientific contact point
- Organisation
- Intas Pharmaceuticals Limited
- Contact name
- Dr. Anoop CH
Public contact point
- Organisation
- Intas Pharmaceuticals Limited
- Contact name
- Dr. Anoop CH
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ongoing, recruiting | 19 | 3 |
| Spain | Ongoing, recruiting | 15 | 6 |
| Rest of world
Turkey, Moldova, Republic of, Brazil, Chile, Mexico, Bosnia and Herzegovina, Argentina, Korea, Republic of, South Africa
|
— | 306 | — |
Investigational sites
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Quironsalud Malaga
Medical Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario De Badajoz
Medical Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital San Pedro De Alcantara
Medical Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
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 |
|---|---|---|---|---|---|
| Romania | 2026-01-19 | 2026-01-20 | |||
| Spain | 2026-03-04 | 2026-04-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Spain | Acceptable 2025-12-01
|
2025-12-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-14 | Spain | Acceptable | 2026-02-13 |