Clinical trial • Phase I • Oncology
AZD5335 for Platinum-resistant recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer | Lung adenocarcinoma | Endometrial cancer
Phase I trial of AZD5335 for Platinum-resistant recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer | Lung adenocarcinoma | Endometrial…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Platinum-resistant recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer | Lung adenocarcinoma | Endometrial cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 29-09-2023
- First CTIS Authorization Date
- 22-01-2024
Trial design
Phase I trial across 11 sites in Spain, Germany.
- Target Sample Size
- 1079
Recruitment
- Planned Sample Size
- 1079
- Recruitment Window Months
- 49
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 70
Spain
- Earliest CTIS Part Ii Submission Date
- 03-11-2023
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 668
- Number Of Sites
- 4
- Number Of Participants
- 53
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- START Madrid-HM CIOCC Early Phase Program
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology Department VHIO
- Contact Person Name
- Ana Oaknin
- Contact Person Email
- aoaknin@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Luis Manso
- Contact Person Email
- luismansosanchez@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- IBIMA
- Contact Person Name
- Javier Garcia Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
Germany
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 346
- Number Of Sites
- 7
- Number Of Participants
- 17
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Frauenheilkunde
- Contact Person Name
- Bahriye Aktas
- Contact Person Email
- bahriye.aktas@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Innere Medizin III Haematologie und Internistische Onkologie
- Contact Person Name
- Daniel Heudobler
- Contact Person Email
- daniel.heudobler@ukr.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Abteilung fuer Gynaekologische Onkologie
- Contact Person Name
- Frederik Marmé
- Contact Person Email
- Frederik.marme@umm.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
- Contact Person Name
- Cornelius Waller
- Contact Person Email
- cornelius.waller@uniklinik-freiburg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik fuer Gynaekologie mit Zentrum fuer onkologische Chirurgie
- Contact Person Name
- Elena Ioana Braicu
- Contact Person Email
- elena.braicu@charite.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Gynaekologie & Gynaekologische Onkologie
- Contact Person Name
- Philipp Harter
- Contact Person Email
- P.Harter@kem-med.com
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Frauenheilkunde und Geburtshilfe
- Contact Person Name
- Tjoung Won Park-Simon
- Contact Person Email
- park-simon.tjoung-won@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD5335
- Combination Treatment
- Yes
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