Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
44
Countries
1
Sites
5
Platinum-resistant, ARID1a-mutated ovarian, fallopian tube and primary peritoneal carcinoma
Key facts
- Sponsor
- Nuvectis Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 30 Jan 2026
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509150-64-00
- ClinicalTrials.gov
- NCT05226507
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Platinum-resistant, ARID1a-mutated ovarian, fallopian tube and primary peritoneal carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073269 | Ovarian endometrioid carcinoma | 100000004864 |
| 20.0 | PT | 10073268 | Ovarian clear cell carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nuvectis Pharma Inc.
- Sponsor organisation
- Nuvectis Pharma Inc.
- Address
- 1 Bridge Plaza North Floor 2
- City
- Fort Lee
- Postcode
- 07024-7586
- Country
- United States
Scientific contact point
- Organisation
- Nuvectis Pharma Inc.
- Contact name
- Chief Development Officer
Public contact point
- Organisation
- Nuvectis Pharma Inc.
- Contact name
- Chief Development Officer
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 8 | 5 |
| Rest of world
United Kingdom, United States
|
— | 36 | — |
Investigational sites
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Vall D'hebron Institut De Recerca
Gynaecologic cancer, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Spain | Acceptable with conditions 2024-03-20
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-28 | Spain | Acceptable 2024-05-20
|
2024-06-21 |