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
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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