Clinical trial • Phase I • Oncology

Mevrometostat for Castration-resistant prostate cancer | Follicular lymphoma | Small cell lung cancer | Diffuse large B-cell lymphoma

Phase I trial of Mevrometostat for Castration-resistant prostate cancer | Follicular lymphoma | Small cell lung cancer | Diffuse large B-cell lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Castration-resistant prostate cancer | Follicular lymphoma | Small cell lung cancer | Diffuse large B-cell lymphoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
07-08-2024
First CTIS Authorization Date
28-08-2024

Trial design

Phase I trial across 26 sites in Bulgaria, Spain, Poland.

Target Sample Size
164

Eligibility

Recruits 164 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the available source..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the available source.

Recruitment

Planned Sample Size
164
Recruitment Window Months
109
Consent Approach
Informed consent approach not described in the provided CTIS JSON; no details on assent or age-specific consent documents or languages available.

Geography

Total Number Of Sites
26
Total Number Of Participants
106

Bulgaria

Earliest CTIS Part Ii Submission Date
20-08-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
24
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Stoil Boychev
Contact Person Email
dr.stoil.boichev@gmail.com
Site Name
Complex Oncology Center Ruse EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Valeriy Ivanov Yordanov
Contact Person Email
dr_vjordanov@abv.bg
Site Name
Complex Oncology Center Vratsa EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Nikolinka Ignatova
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
Department of Medical Oncology and Oncological Diseases in Gastroenterology
Contact Person Name
Antoaneta Tomova
Contact Person Email
dr.tomova@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
20-08-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
566
Number Of Sites
16
Number Of Participants
90

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Contact Person Name
Laura Medina Rodriguez
Contact Person Email
laura.medina@ibima.eu
Site Name
Hospital Universitario Y Politecnico La Fe
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es
Site Name
Institut Catala D'oncologia
Contact Person Name
Josep Maria Piulats Rodriguez
Contact Person Email
jmpiulats@ico.scs.es
Site Name
Hospital Universitario Hm Sanchinarro
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
Irene.moreno@startmadrid.com
Site Name
Hospital Clinico Universitario De Valencia
Contact Person Name
Maria Isabel Chirivella Gonzalez
Contact Person Email
chirivella_isa@gva.es
Site Name
Hospital Universitario 12 De Octubre
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Contact Person Name
Georgia Anguera Palacios
Contact Person Email
GAnguera@santpau.cat
Site Name
Hospital Quironsalud Barcelona
Contact Person Name
Fabricio Racca Bussano
Contact Person Email
fracca@nextoncology.eu
Site Name
Hospital Clinico San Carlos
Department Name
Oncology Service
Contact Person Name
Jorge Bartolome Arcilla
Site Name
Consorcio Hospitalario Provincial De Castellon
Contact Person Name
Alfredo Sanchez Hernandez
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Clinic De Barcelona
Contact Person Name
Begoña Mellado Gonzalez
Contact Person Email
bmellado@clinic.cat
Site Name
Hospital Universitario Ramon Y Cajal
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Hm Nou Delfos
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Contact Person Name
David Humberto Marmolejo Castañeda
Contact Person Email
davidmarmolejo@vhio.net
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
NEXT Madrid Phase I trials
Contact Person Name
Jesus Fuentes Antras
Contact Person Email
jfuentesantras@nextoncology.eu

Poland

Earliest CTIS Part Ii Submission Date
20-08-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
51
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Jagiellonskie Centrum Innowacji Sp. z o.o.
Contact Person Name
Renata Pacholczak-Madej
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Contact Person Name
Kamil Stanislaw Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Contact Person Name
Iwona Lugowska
Contact Person Email
iwona.lugowska@coi.pl
Site Name
Lux Med Onkologia Sp. z o.o.
Contact Person Name
Jakub Zolnierek
Contact Person Email
qbazolnier@wp.pl
Site Name
In Vivo Sp. z o.o.
Contact Person Name
Anna Krause
Contact Person Email
akrause@interia.pl

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Mevrometostat

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