Clinical trial • Phase IV • Oncology

talazoparib for Urothelial carcinoma | Locally advanced or metastatic urothelial carcinoma

Phase IV trial of talazoparib for Urothelial carcinoma | Locally advanced or metastatic urothelial carcinoma. None/Not specified-controlled.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Urothelial carcinoma | Locally advanced or metastatic urothelial carcinoma
Trial Stage
Phase IV
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
09-09-2024
First CTIS Authorization Date
06-12-2024

Trial design

None/Not specified-controlled Phase IV trial across 15 sites in France.

Comparator
None/Not specified
Target Sample Size
45

Eligibility

Recruits 45 No vulnerable populations selected; no specific consent or assent handling described in the record..

Vulnerable Population
No vulnerable populations selected; no specific consent or assent handling described in the record.

Recruitment

Planned Sample Size
45
Recruitment Window Months
59
Consent Approach
Informed consent not detailed in record; no assent or age-specific consent documents described.

Geography

Total Number Of Sites
15
Total Number Of Participants
45

France

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
06-12-2024
Processing Time Days
7
Number Of Sites
15
Number Of Participants
45

Sites

Site Name
Institut Paoli Calmettes
Department Name
Oncology
Contact Person Name
Gwenaelle GRAVIS
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Contact Person Name
Damien POUESSEL
Site Name
Centre Antoine Lacassagne
Department Name
Oncology
Contact Person Name
Delphine BORCHIELLINI
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Contact Person Name
Friederike SCHLUMANN
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Contact Person Name
Elouen BOUGHALEM
Site Name
Hopital Tenon
Department Name
Oncology
Contact Person Name
Ahmed KHALIL
Contact Person Email
ahmed.khalil@aphp.fr
Site Name
Centre Francois Baclesse
Department Name
Oncology
Contact Person Name
Elodie COQUAN
Contact Person Email
e.coquan@baclesse.unicancer.fr
Site Name
CHU Besancon
Department Name
Oncology
Contact Person Name
Fabien CALCAGNO
Contact Person Email
fabien.calcagno@gmail.com
Site Name
Centr Georges Francois Leclerc
Department Name
Oncology
Contact Person Name
Sylvain LADOIRE
Contact Person Email
sladoire@cgfl.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Contact Person Name
Laurence CROUZET
Contact Person Email
l.crouzet@rennes.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Oncology
Contact Person Name
Aude FLECHON
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncology
Contact Person Name
Elouen BOUGHALEM
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Contact Person Name
Denis MAILLET
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Contact Person Name
Hakim MAHAMMEDI
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncology
Contact Person Name
Camille SERRATE
Contact Person Email
cserrate@hopital-dcss.org

Sponsor

Primary sponsor

Full Name
Centre Francois Baclesse
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Talazoparib
Active Substance
talazoparib
Modality
Small molecule
Investigational Product Name
Avelumab
Active Substance
avelumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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