Clinical trial • Phase III • Oncology
AZD5335 for Ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Phase III trial of AZD5335 for Ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer. 34 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-09-2025
- First CTIS Authorization Date
- 15-01-2026
Trial design
Phase III trial across 6 sites in Spain, Ireland, Portugal.
- Target Sample Size
- 34
Eligibility
Recruits 34 Vulnerable population selected; consent/assent procedures not specified in the provided documents..
- Vulnerable Population
- Vulnerable population selected; consent/assent procedures not specified in the provided documents.
Recruitment
- Planned Sample Size
- 34
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 34
Spain
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- 7002: CIOCC Early Phase
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- 7001: CIOCC Phase I Unit
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- 7004: Phase I Clinical Trials Unit
- Contact Person Name
- Ester Garcia Lorenzo
- Contact Person Email
- ester.garcia@startmadrid.com
- Site Name
- Fundacion Rioja Salud
- Department Name
- 7003: Early Phase Clinical Trials
- Contact Person Name
- Maria de Miguel
- Contact Person Email
- maria.demiguel@startrioja.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 36
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- 3901: START Dublin
- Contact Person Name
- Austin Duffy
- Contact Person Email
- austinduffy@mater.ie
Portugal
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 96
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Start Research Portugal Unipessoal Lda.
- Department Name
- 351217805000
- Contact Person Name
- Andre Mansinho
- Contact Person Email
- andr3.m@gmail.com
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD5335
- Active Substance
- AZD5335
- Modality
- Small molecule
- Investigational Product Name
- Itraconazole
- Active Substance
- Itraconazole
- Modality
- Small molecule
- Combination Treatment
- Yes
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