Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
300
Countries
4
Sites
16
Pancreatic Ductal Adeno Carcinoma
Key facts
- Sponsor
- Kura Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Mar 2025 → ongoing
- Decision date (initial)
- 2025-01-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513285-19-00
- ClinicalTrials.gov
- NCT06026410
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pancreatic Ductal Adeno Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kura Oncology Inc.
- Sponsor organisation
- Kura Oncology Inc.
- Address
- 4930 Directors Place Suite 500
- City
- San Diego
- Postcode
- 92121-3848
- Country
- United States
Scientific contact point
- Organisation
- Kura Oncology Inc.
- Contact name
- Kura Medical Information
Public contact point
- Organisation
- Kura Oncology Inc.
- Contact name
- Kura Medical Information
Locations
4 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 15 | 4 |
| Germany | Ongoing, recruiting | 8 | 3 |
| Italy | Ongoing, recruiting | 27 | 5 |
| Spain | Ongoing, recruiting | 16 | 4 |
| Rest of world
United States
|
— | 234 | — |
Investigational sites
Oncopole Claudius Regaud
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Oncologie Médicale, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Assistance Publique Hopitaux De Paris
Oncologie Médicale, 20 Rue Leblanc, 75015, Paris
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Charite Universitaetsmedizin Berlin KöR
Med. Klinik m.S. Hämato-Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum, Josef-Schneider-Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm (CCCU) – Early Clinical Trials Unit (ECTU), Albert-Einstein-Allee 23, Eselsberg, Ulm
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Ricerca Traslazionale a Servizio dei percorsi oncologici, Via Mariano Semmola 52, 80131, Naples
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Section, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
SC Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncology and Haematology, Via Pietro Albertoni 15, 40138, Bologna
Humanitas Mirasole S.p.A.
U.O di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| France | 2025-03-14 | 2025-05-06 | |||
| Germany | 2026-03-23 | 2026-04-01 | |||
| Italy | 2025-04-04 | 2025-04-22 | |||
| Spain | 2025-03-28 | 2025-04-07 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Spain | Acceptable 2025-01-30
|
2025-01-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-19 | Spain | Acceptable 2025-01-30
|
2025-02-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-26 | Acceptable | 2025-03-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-27 | Spain | Acceptable | 2025-04-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-10 | Spain | Acceptable 2025-09-15
|
2025-09-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-10 | Spain | Acceptable 2025-09-15
|
2025-10-10 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-17 | Spain | Acceptable 2025-09-15
|
2025-11-17 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-04 | Spain | Acceptable 2026-03-09
|
2026-03-09 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-17 | Acceptable | 2026-04-20 |