Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
120
Countries
1
Sites
6
Platinum-Resistant ovarian cancer
Key facts
- Sponsor
- Stemline Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-524168-39-00
- WHO UTN
- U1111-1330-4197
- ClinicalTrials.gov
- NCT07226427
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Platinum-Resistant ovarian cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stemline Therapeutics Inc.
- Sponsor organisation
- Stemline Therapeutics Inc.
- Address
- 750 Lexington Avenue
- City
- New York
- Postcode
- 10022-1200
- Country
- United States
Scientific contact point
- Organisation
- Stemline Therapeutics Inc.
- Contact name
- Clinical Development and Clinical Operations
Public contact point
- Organisation
- Stemline Therapeutics Inc.
- Contact name
- Clinical Development and Clinical Operations
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 23 | 6 |
| Rest of world
United States, Australia
|
— | 97 | — |
Investigational sites
Hospital Universitario Hm Sanchinarro
034-04: Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
034-01: Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
034-06: Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico Universitario De Valencia
034-05: Oncologia Médica y Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Clinica Universidad De Navarra
034-02: Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Instituto Oncologico Dr. Rosell S.L.
034-03: Oncology, Calle De Sabino Arana Num. 5, 08028, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2026-04-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-24 | Spain | Acceptable with conditions 2026-03-20
|
2026-03-23 |