Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
171
Countries
3
Sites
8
Relapsed and/or refractory Acute Myeloid Leukemia
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
- 1 Nov 2024 → ongoing
- Decision date (initial)
- 2024-08-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510288-37-00
- ClinicalTrials.gov
- NCT06001788
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or refractory Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10060558 | Acute myeloid leukemia recurrent | 10029104 |
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
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 1 |
| Italy | Ongoing, recruiting | 10 | 3 |
| Spain | Ongoing, recruiting | 10 | 4 |
| Rest of world
United States
|
— | 141 | — |
Investigational sites
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Haematology, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
Haematology, Via Alcide De Gasperi 8, 48121, Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Haematology, Largo Francesco Vito 1, 00168, Rome
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Central De Asturias
Hematology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Italy | 2024-12-05 | 2024-12-12 | |||
| Spain | 2024-11-01 | 2024-11-04 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-20 | Spain | Acceptable 2024-08-22
|
2024-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-06 | Acceptable | 2024-11-06 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-06 | Spain | 2024-11-06 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-14 | Spain | Acceptable 2025-05-06
|
2025-05-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-02 | Spain | Acceptable with conditions 2025-08-27
|
2025-08-31 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-16 | Spain | Acceptable with conditions 2025-08-27
|
2026-01-16 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-20 | Spain | Acceptable with conditions 2025-08-27
|
2026-04-20 |