Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
640
Countries
8
Sites
48
Breast Cancer
Key facts
- Sponsor
- Stemline Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Dec 2023 → ongoing
- Decision date (initial)
- 2023-10-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-503114-23-00
- WHO UTN
- U1111-1286-9637
- ClinicalTrials.gov
- NCT05386108
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
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
- Carlos A. Garay, MD
Public contact point
- Organisation
- Stemline Therapeutics Inc.
- Contact name
- Carlos A. Garay, MD
Locations
8 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 40 | 5 |
| Czechia | Ended | 40 | 2 |
| France | Ongoing, recruiting | 40 | 5 |
| Germany | Ended | 40 | 7 |
| Hungary | Ended | 40 | 2 |
| Italy | Ongoing, recruiting | 40 | 8 |
| Poland | Ended | 40 | 5 |
| Spain | Ongoing, recruiting | 40 | 14 |
| Rest of world
Turkey, United States, Argentina, Brazil, Australia, Korea, Republic of, United Kingdom, Israel
|
— | 320 | — |
Investigational sites
UZ Leuven
Gynaecological Oncology, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Clinical Trials Conduct Unit, Mijlenmeersstraat 90, 1070, Brussels
Vitaz
Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Grand Hopital De Charleroi
Oncology and Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Hopital De Libramont
Oncology, Avenue De Houffalize 35, 6800, Libramont-Chevigny
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Onkologická ambulance Nemocnice Hořovice - Multiscan s.r.o.
Onkologie, K Nemocnici 1106/14, 268 01, Hořovice
Centre Hospitalier Lyon Sud
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre De Cancerologie Du Grand Montpellier
Medical Oncology, 25 Rue De Clementville, 34070, Montpellier
Institut Gustave Roussy
Medical Oncology and Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Henri Becquerel
Medical Oncology, 1 Rue D Amiens, 76000, Rouen
Marienhospital Bottrop gGmbH
Gynäkologie, Josef-Albers-Strasse 70, Sued-West-Innenstadt, Bottrop
Universitaetsklinikum Tuebingen AöR
Department für Frauengesundheit, Calwerstrasse 7, Innenstadt, Tuebingen
Universitaetsklinikum Mannheim GmbH
Gynäkologie/ Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Technische Universitat Dresden
Medizinische Fakultät Carl Gustav Carus; Gynäkologisches Krebszentrum, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum Kassel GmbH
Klinik für Frauenheilkunde und Geburtshilfe, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Klinikum rechts der Isar der TU Muenchen AöR
Frauenklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
KEM I Evang. Kliniken Essen-Mitte gGmbH
Senologie/ Brustzentrum, Henricistrasse 92, Huttrop, Essen
Orszagos Onkologiai Intezet
-, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis Egyetem
Belgyógyászati és Onkológiai Klinika, Baross Utca 23, 1082, Budapest
Azienda Unita Sanitaria Locale Della Romagna
Dep. of Oncology, Via Ludwig Van Beethoven 1, 47841, Cattolica
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Oncologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Parma
Dipartimento di Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Azienda Unita Sanitaria Locale Della Romagna
Dipartimento di Oncologia, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia, Via Roma 67, 56126, Pisa
European Institute Of Oncology S.r.l.
Dipartimento Divisione di sviluppo di nuovi farmaci per tapie innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Oncologia Clinica Sperimentale di Senologia, Via Mariano Semmola 52, 80131, Naples
Azienda Istituti Ospitalieri Di Cremona
U.O. Patologia Mammaria e Ricerca Traslazionale, Viale Concordia 1, 26100, Cremona
Med Polonia Sp. z o.o.
Med-Polonia SP.z o.o., Obornicka 262, 60-693, Poznan
Przychodnia Lekarska KOMED Roman Karaszewski
Przychodnia Lekarska KOMED Roman Karaszewski, Wojska Polskiego 6, 62-500, Konin
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Centrum Wsparcia Badań Klinicznyh, Ulica Szaserow 128, 04-141, Warsaw
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Pododdział Chemioterapii, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Ruber Internacional
Oncology, Calle La Maso 38, 28035, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Clinic De Barcelona
Oncology, Calle Rosellon 138, 08036, Barcelona
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle De Gregorio Gea 3, Edificio Consultas Externas 1ª Planta, Valencia
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Belgium | 2024-04-25 | 2024-05-13 | |||
| Czechia | 2024-01-19 | ||||
| France | 2024-04-17 | 2024-06-10 | |||
| Germany | 2024-06-11 | ||||
| Hungary | 2023-12-19 | ||||
| Italy | 2024-04-05 | 2024-05-09 | |||
| Poland | 2024-05-07 | ||||
| Spain | 2024-01-30 | 2024-02-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-02-23
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-07 | Belgium | Acceptable with conditions 2023-10-18
|
2023-10-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-29 | Belgium | Acceptable with conditions 2024-02-09
|
2024-02-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-27 | Belgium | Acceptable with conditions 2024-02-09
|
2024-02-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-28 | Acceptable with conditions | 2024-03-20 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-03-27 | Belgium | Acceptable with conditions | 2024-03-27 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-04-05 | Belgium | Acceptable with conditions | 2024-04-05 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-06-19 | Acceptable with conditions | 2024-06-19 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-11 | Belgium | Acceptable with conditions 2024-10-08
|
2024-10-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-12 | Belgium | Acceptable with conditions | 2025-01-10 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-01 | Belgium | Acceptable 2025-10-14
|
2025-10-14 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-30 | Acceptable 2025-10-14
|
2025-10-30 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-11 | Acceptable | 2026-03-13 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-03-13 | Belgium | 2026-03-13 |