Clinical trial • Phase III • Oncology

5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one for Metastatic castration-resistant prostate cancer

Phase III trial of 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-08-2024
First CTIS Authorization Date
08-01-2025

Trial design

Randomised, investigational arm a: pf-06821497 875mg bid + enzalutamide 160 mg qd; comparator arm b: placebo bid + enzalutamide 160 mg qd-controlled Phase III trial in Italy, Slovakia, Sweden and others.

Randomised
Yes
Comparator
Investigational Arm A: PF-06821497 875mg BID + enzalutamide 160 mg QD; Comparator Arm B: Placebo BID + enzalutamide 160 mg QD
Target Sample Size
572

Stratification factors

  • Previous treatment with docetaxel for mCSPC (yes vs. no)
  • Presence of hepatic metastases (yes vs. no)

Eligibility

Recruits 572 No vulnerable populations selected. Study enrols adult male participants (≥18 years or minimum age of consent per local regulations). Informed consent is to be provided by the participant (no assent provisions described). Country-specific subject information and informed consent documents (and addenda for privacy, retained samples, pregnant partner information where relevant) are prepared for participating countries..

Vulnerable Population
No vulnerable populations selected. Study enrols adult male participants (≥18 years or minimum age of consent per local regulations). Informed consent is to be provided by the participant (no assent provisions described). Country-specific subject information and informed consent documents (and addenda for privacy, retained samples, pregnant partner information where relevant) are prepared for participating countries.

Inclusion criteria

  • {"criterion_text":"- Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.\n- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology). For participants without a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis.\n- Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.\n- Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.\n- Progressive disease in the setting of medical or surgical castration as defined by meeting 1 or more of the following 3 criteria: a. Prostate specific antigen (PSA) progression defined by rising PSA of at least 2 consecutive rises in most recent PSA to be documented over a reference value (measure 1) taken at least 7 days apart within the last 12 months. If the third PSA measure is not greater than the second measure, a fourth PSA measure is required to be taken and be greater than the second measure. The last of these PSA values, obtained before randomization must be ≥1 μg/L if qualifying only by PSA progression; b. Soft tissue disease progression as defined by RECIST 1.1.; c. Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.\n- Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs such as alopecia and peripheral neuropathy not constituting a safety risk in the investigator’s judgment).\n- ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator."}

Exclusion criteria

  • {"criterion_text":"- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.\n- Inadequate renal function defined by an eGFR <45 mL/min/1.73 m².. Based upon participant age at screening, eGFR is calculated using the recommended formulas in Section 10.7.1 to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events.\n- Hepatic dysfunction defined as: a. Total bilirubin ≥1.5 × ULN; b. AST >2.5 × ULN; c. ALT >2.5 × ULN\n- Hematologic abnormalities defined as: a. ANC <1500/mm3; b. Platelets <100,000/μL; c. Hemoglobin <9 g/dL, independent of transfusion within 14 days of randomization\n- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.\n- Clinically significant cardiovascular disease, defined as: a. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2; b. Cardiac rhythm device/pacemaker.; c. QTcF >480 msec on screening ECG.\n- CNS pathology/neurological findings: a. Known or suspected brain metastasis or active leptomeningeal disease.; b. Symptomatic or impending spinal cord compression or cauda equina syndrome.; c. Participants with epidural disease, canal disease and prior cord involvement are NOT excluded if those areas have been treated, are stable, and not neurologically impaired.; d. Clinically significant history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of unexplained loss of consciousness or transient ischemic attack within 12 months of randomization.\n- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy except for any of the following: a. Carcinoma in situ or non-melanoma skin cancer.; b. Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.; c. Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator.\n- Participants must be treatment naïve at the mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy (includes but not limited to docetaxel), received ARSI/ abiraterone acetate in mCRPC, mCSPC or non-metastatic PC. Prior docetaxel in mCSPC is allowed.\n- Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to randomization are not permitted.\n- Previous administration with an investigational product (drug or vaccine which does not meet exclusion criterion 5 above) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n- Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study) outlined in Section 6.9.1 and Section 6.9.2, including their administration within 10 days or 5 half-lives, whichever is longer prior to randomization.\n- Major surgery or palliative localized radiation therapy within 14 days before randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease).","definition_or_measurement_approach":"Assessed by Blinded Independent Central Review (BICR) using RECIST 1.1 for measurable soft tissue disease and PCWG3 criteria for bone disease (radiographic progression-free survival, rPFS)."}

Secondary endpoints

  • {"endpoint_text":"- OS (alpha protected)\n- TTPP (alpha protected): assessed using time to first ≥2- point increase from baseline score on BPISF Item 3 (Worst Pain) observed at 2 consecutive visits or the initiation of short- or long-acting opioid use for pain\n- Proportion of participants with measurable soft tissue disease at baseline with an objective response per RECIST 1.1 (assessed by BICR)\n- Duration of soft tissue response per RECIST 1.1 (assessed by BICR)\n- Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline\n- Time to PSA progression\n- Time to initiation of new antineoplastic therapy\n- Time to initiation of cytotoxic chemotherapy\n- Time to first symptomatic skeletal event\n- PFS2 based on investigator assessment separately\n- Type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness and relationship to study medications of AEs and any laboratory test and ECG abnormalities\n- ctDNA burden at baseline and on study\n- PK characterized by pre-dose trough and post-dose plasma concentrations of PF- 06821497 at selected visits\n- Change from baseline in participant reported pain symptoms per BPI-SF; Change from baseline in BPI-SF Item 3 (Worst Pain) at Cycle 7 Day 1 (Week 25); Change from baseline in HRQoL, functioning and symptoms per FACT-P; Change from baseline in participant reported health status per EQ- 5D-5L; Symptomatic toxicity and the overall side effect burden as measured by items from the PRO-CTCAE and FACT-GP5; Time to definitive deterioration in participant reported HRQoL and physical well-being per FACT-P","definition_or_measurement_approach":"Definitions/measurement approaches provided where available: OS = overall survival (alpha-protected). TTPP = time to first ≥2-point increase from baseline on BPI-SF Item 3 observed at 2 consecutive visits or start of opioid use for pain. Objective response and duration of response for soft tissue disease assessed per RECIST 1.1 by BICR. PSA response defined as ≥50% decline in PSA in participants with detectable baseline PSA. Safety assessed by NCI CTCAE v5.0; PK via pre-dose trough and post-dose plasma concentrations at selected visits; ctDNA burden measured at baseline and on study; PROs by BPI-SF, FACT-P, EQ-5D-5L, PRO-CTCAE and FACT-GP5 per protocol-specified timepoints."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
572
Recruitment Window Months
73
Consent Approach
Informed consent is obtained from each participant (adult male participants aged ≥18 years or the minimum age of consent per local regulations). Country-specific subject information and informed consent forms (ICFs) and addenda are provided (multiple country-language versions are listed: English and local-language translations for Italy, Slovakia, Sweden, Netherlands, France, Germany, Greece, Poland, Finland, Bulgaria, Hungary, Spain, Czechia, etc.). Documents include main ICF, ICD addenda, privacy supplements, optional retained research sample consents, pregnant partner information where relevant, and study-specific informational flipbooks. Consent is provided directly by the participant; no assent procedures for minors are applicable per eligibility (adults only).

Methods

  • Investigator/site-based recruitment via oncology and urology clinics at participating hospitals (site contact details provided per country).
  • Third-party patient recruitment vendors (WCG Clinical Inc., Innovative Trials Limited, Clariness GmbH, Scout Clinical) engaged to support patient identification and recruitment.
  • Patient-facing printed materials: program brochure inserts, program flyers, program posters, study brochure inserts distributed at sites.
  • Digital recruitment materials: study pages and programmatic pages, patient video and patient video storyboard, programmatic pages (country-specific versions).
  • Search engine advertising and search engine advertisement text (documented for Netherlands and other countries).
  • QR postcards and program QR post cards linking to study pages.
  • HCP referral letters (explicitly listed for Hungary) and healthcare professional referral pathways.
  • Retention incentives described (retention items such as headphones and socks) and related submission forms listed in recruitment materials.

Geography

Total Number Of Sites
79
Total Number Of Participants
328

Italy

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
515
Number Of Sites
10
Number Of Participants
25

Sites

Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Medical Oncology
Principal Investigator Name
Giampaolo Tortora
Principal Investigator Email
giampaolo.tortora@policlinicogemelli.it
Contact Person Name
Giampaolo Tortora
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Principal Investigator Name
Andrea Zivi
Principal Investigator Email
andrea.zivi@aovr.veneto.it
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology 1
Principal Investigator Name
Fabio Calabro
Principal Investigator Email
fabio.calabro@ifo.it
Contact Person Name
Fabio Calabro
Contact Person Email
fabio.calabro@ifo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. di Oncologia medica ed Ematologia
Principal Investigator Name
Paolo Andrea Zucali
Principal Investigator Email
paolo.zucali@cancercenter.humanitas.it
Contact Person Name
Paolo Andrea Zucali
Site Name
Azienda Sanitaria Universitaria Integrata Del Trentino
Department Name
Medical Oncology
Principal Investigator Name
Orazzio Caffo
Principal Investigator Email
orazio.caffo@apss.tn.it
Contact Person Name
Orazzio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
Unità Operativa di Oncologia
Principal Investigator Name
Bruno Perrucci
Principal Investigator Email
bruno.perrucci@asst-cremona.it
Contact Person Name
Bruno Perrucci
Contact Person Email
bruno.perrucci@asst-cremona.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Medical Oncology
Principal Investigator Name
Giuseppe Schepisi
Principal Investigator Email
giuseppe.schepisi@irst.emr.it
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SSD Oncologia Clinica-Sperimentale di Uro-Andrologia
Principal Investigator Name
Sabrina Rossetti
Principal Investigator Email
s.rossetti@istitutotumori.na.it
Contact Person Name
Sabrina Rossetti
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncologia Medica e Traslazionale
Principal Investigator Name
Annalisa Guida
Principal Investigator Email
a.guida@aospterni.it
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it

Slovakia

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
493
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Privatna Urologicka Ambulancia s.r.o.
Principal Investigator Name
Roman Sokol
Principal Investigator Email
roman.sokol@urology.sk
Contact Person Name
Roman Sokol
Contact Person Email
roman.sokol@urology.sk
Site Name
Cuimed s.r.o.
Principal Investigator Name
Frederico Manuel Figueiredo Goncalves
Principal Investigator Email
goncalves@chello.sk
Contact Person Name
Frederico Manuel Figueiredo Goncalves
Contact Person Email
goncalves@chello.sk
Site Name
Univerzitna Nemocnica Martin
Department Name
Urologicka klinika JLF UK a UNM
Principal Investigator Name
Ján Ľupták
Principal Investigator Email
jan.luptak@uniba.sk
Contact Person Name
Ján Ľupták
Contact Person Email
jan.luptak@uniba.sk

Sweden

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
518
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Soedersjukhuset AB
Department Name
Oncology
Principal Investigator Name
Li Chunde
Principal Investigator Email
chunde.li@sll.se
Contact Person Name
Li Chunde
Contact Person Email
chunde.li@sll.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Verksamhet onkologi, Blå Stråket 2
Principal Investigator Name
Molin Claes
Principal Investigator Email
claes.molin@vgregion.se
Contact Person Name
Molin Claes
Contact Person Email
claes.molin@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Klinisk Forskningsenhet, VE Onkologi, Jan Waldenströms Gata 18
Principal Investigator Name
Ståhl Olof
Principal Investigator Email
olof.stahl@skane.se
Contact Person Name
Ståhl Olof
Contact Person Email
olof.stahl@skane.se

Netherlands

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
496
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Sint Franciscus Vlietland Groep Stichting
Principal Investigator Name
Paul Hamberg
Principal Investigator Email
p.hamberg@franciscus.nl
Contact Person Name
Paul Hamberg
Contact Person Email
p.hamberg@franciscus.nl
Site Name
Frisius MC
Principal Investigator Name
Marco Polee
Principal Investigator Email
m.polee@mcl.nl
Contact Person Name
Marco Polee
Contact Person Email
m.polee@mcl.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Principal Investigator Name
Andre Bergman
Principal Investigator Email
a.bergman@nki.nl
Contact Person Name
Andre Bergman
Contact Person Email
a.bergman@nki.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Principal Investigator Name
Diederik Somford
Principal Investigator Email
r.somford@cwz.nl
Contact Person Name
Diederik Somford
Contact Person Email
r.somford@cwz.nl

France

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
499
Number Of Sites
10
Number Of Participants
48

Sites

Site Name
Clinique Victor Hugo (Centre De Cancerologie De La Sarthe)
Department Name
Oncology - Radiotherapy
Principal Investigator Name
Ossama Didas
Principal Investigator Email
essaisdidas@ilcgroupe.fr
Contact Person Name
Ossama Didas
Contact Person Email
essaisdidas@ilcgroupe.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Principal Investigator Name
Denis Maillet
Principal Investigator Email
denis.maillet@chu-lyon.fr
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Institut Bergonie
Department Name
Oncology
Principal Investigator Name
Guilhem Roubaud
Principal Investigator Email
g.roubaud@bordeaux.unicancer.fr
Contact Person Name
Guilhem Roubaud
Site Name
Les Hôpitaux Universitaires de Strasbourg – Hôpital de Hautepierre
Department Name
Medical Oncology
Principal Investigator Name
Philippe Barthelemy
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de cancérologie et hématologie
Principal Investigator Name
Benjamin Auberger
Principal Investigator Email
benjamin.auberger@chu-brest.fr
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Principal Investigator Name
Emmanuelle Bompas
Principal Investigator Email
emmanuelle.bompas@ico.unicancer.fr
Contact Person Name
Emmanuelle Bompas
Site Name
Centre Jean Perrin
Department Name
Oncology
Principal Investigator Name
Hakim Mahammedi
Principal Investigator Email
hakim.mahammedi@clermont.unicancer.fr
Contact Person Name
Hakim Mahammedi
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Oncology
Principal Investigator Name
Aurélien Gobert
Principal Investigator Email
aurelien.gobert@icrb.fr
Contact Person Name
Aurélien Gobert
Contact Person Email
aurelien.gobert@icrb.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Aude Flechon
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude Flechon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut Godinot
Department Name
Oncology
Principal Investigator Name
Jean-Christophe Eymard
Principal Investigator Email
jc.eymard@reims.unicancer.fr
Contact Person Name
Jean-Christophe Eymard
Contact Person Email
jc.eymard@reims.unicancer.fr

Germany

Earliest CTIS Part Ii Submission Date
04-12-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
504
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Praxis für Urologie
Principal Investigator Name
Tilman Todenhöfer
Principal Investigator Email
todenhoefer@studienurologie.de
Contact Person Name
Tilman Todenhöfer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Klinik für Urologie
Principal Investigator Name
Steffen Rausch
Principal Investigator Email
steffen.rausch@med.uni-tuebingen.de
Contact Person Name
Steffen Rausch
Site Name
Universitaet Muenster
Department Name
Klinik für Urologie
Principal Investigator Name
Martin Bögemann
Principal Investigator Email
martin.boegemann@ukmuenster.de
Contact Person Name
Martin Bögemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Urologie
Principal Investigator Name
Gunhild von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de

Greece

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
587
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Alexandra Hospital
Department Name
Oncology Department
Principal Investigator Name
Michalis Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Department of Propaedeutic and Internal Medicine
Principal Investigator Name
Aristotelis Bamias
Principal Investigator Email
abamias@med.uoa.gr
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
kotsakisthan@gmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Marinos Tsiatas
Principal Investigator Email
tsiatas@hotmail.com
Contact Person Name
Marinos Tsiatas
Contact Person Email
tsiatas@hotmail.com
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
Oncologic Clinical Trials and Research Clinic
Principal Investigator Name
Evangelos Bournakis
Principal Investigator Email
vagimith@yahoo.com
Contact Person Name
Evangelos Bournakis
Contact Person Email
vagimith@yahoo.com
Site Name
General University Hospital Of Larissa (duplicate listing not expected)
Department Name
Oncology Clinic
Contact Person Name
placeholder

Poland

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
497
Number Of Sites
10
Number Of Participants
60

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Principal Investigator Name
Barbara Radecka
Principal Investigator Email
brad@onkologia.opole.pl
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Department Name
Oddzial Onkologii Klinicznej
Principal Investigator Name
Urszula Sadowska
Principal Investigator Email
ula@stolcad.pl
Contact Person Name
Urszula Sadowska
Contact Person Email
ula@stolcad.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Michał Masłowski
Principal Investigator Email
maslowskimichal@gmail.com
Contact Person Name
Michał Masłowski
Contact Person Email
maslowskimichal@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Ukladu Moczowego
Principal Investigator Name
Paweł Wiechno
Principal Investigator Email
wiechno@gmail.com
Contact Person Name
Paweł Wiechno
Contact Person Email
wiechno@gmail.com
Site Name
MICS Centrum Medyczne Torun
Department Name
Dzial Badan Klinicznych
Principal Investigator Name
Przemysław Adamczyk
Principal Investigator Email
d.chraniuk@naszlekarz.pl
Contact Person Name
Przemysław Adamczyk
Contact Person Email
d.chraniuk@naszlekarz.pl
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Principal Investigator Name
Renata Pacholczak-Madej
Principal Investigator Email
renata.pacholczakmadej@gmail.com
Contact Person Name
Renata Pacholczak-Madej
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Principal Investigator Name
Pawel Plaza
Principal Investigator Email
pawel.plaza@gmail.com
Contact Person Name
Pawel Plaza
Contact Person Email
pawel.plaza@gmail.com
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
KLINICZNY ODDZIAŁ ONKOLOGII KLINICZNEJ
Principal Investigator Name
Beata Freier
Principal Investigator Email
beatafreier.bf@gmail.com
Contact Person Name
Beata Freier
Contact Person Email
beatafreier.bf@gmail.com
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Principal Investigator Name
Anna Kowalczyk-Tekiela
Principal Investigator Email
atekiela@interia.pl
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@interia.pl

Denmark

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
494
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Odense University Hospital
Department Name
Dept of Oncology
Principal Investigator Name
Steinbjoern Hansen
Principal Investigator Email
steinbjoern.hansen@rsyd.dk
Contact Person Name
Steinbjoern Hansen
Contact Person Email
steinbjoern.hansen@rsyd.dk
Site Name
Sygehus Lillebaelt Vejle Sygehus
Principal Investigator Name
Louise Raunkilde
Principal Investigator Email
louise.raunkilde.larsen@rsyd.dk
Contact Person Name
Louise Raunkilde
Site Name
Næstved Hospital
Department Name
Oncology Dept.
Principal Investigator Name
Anne Christensen
Principal Investigator Email
anjc@regionsjaelland.dk
Contact Person Name
Anne Christensen
Contact Person Email
anjc@regionsjaelland.dk

Bulgaria

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
500
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Department Name
Department of Medical Oncology
Principal Investigator Name
Velko Minchev
Principal Investigator Email
v_minchev@abv.bg
Contact Person Name
Velko Minchev
Contact Person Email
v_minchev@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Department of Medical Oncology
Principal Investigator Name
Yordan Ignatov
Principal Investigator Email
yordanignatov@abv.bg
Contact Person Name
Yordan Ignatov
Contact Person Email
yordanignatov@abv.bg
Site Name
Complex Oncology Center Stara Zagora Ltd.
Department Name
Department of Medical Oncology
Principal Investigator Name
Tatyana Todorova-Andreeva
Principal Investigator Email
dr.tatyana.andreeva@gmail.com
Contact Person Name
Tatyana Todorova-Andreeva
Contact Person Email
dr.tatyana.andreeva@gmail.com
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
First department of medical oncology and oncology diseases in gastroenterology
Principal Investigator Name
Antoaneta Tomova
Principal Investigator Email
dr.tomova@gmail.com
Contact Person Name
Antoaneta Tomova
Contact Person Email
dr.tomova@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Department Name
Department of Medical Oncology
Principal Investigator Name
Bonka Popova
Principal Investigator Email
dr.bonka.popova@gmail.com
Contact Person Name
Bonka Popova
Contact Person Email
dr.bonka.popova@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
496
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Urogenitális Tumorok és Klinikai Farmakologiai Osztaly
Principal Investigator Name
Lajos Geczi
Principal Investigator Email
geczi.lajos@oncol.hu
Contact Person Name
Lajos Geczi
Contact Person Email
geczi.lajos@oncol.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Klinikai Onkologiai es Sugarterapias Centrum
Principal Investigator Name
Gergely Dombovari
Principal Investigator Email
dombovaridr@freemail.hu
Contact Person Name
Gergely Dombovari
Contact Person Email
dombovaridr@freemail.hu
Site Name
Nograd Varmegyei Szent Lazar Korhaz
Department Name
Onkologia és Sugarterapias Osztaly
Principal Investigator Name
Laszlo Landherr
Principal Investigator Email
landherr@szlmk.hu
Contact Person Name
Laszlo Landherr
Contact Person Email
landherr@szlmk.hu

Spain

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
589
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Onccology Department
Principal Investigator Name
Juan Rodriguez Moreno
Principal Investigator Email
jfrodriguez@hmhospitales.com
Contact Person Name
Juan Rodriguez Moreno
Contact Person Email
jfrodriguez@hmhospitales.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Onccology
Principal Investigator Name
Maria Juan Fita
Principal Investigator Email
mjuanfi81@hotmail.com
Contact Person Name
Maria Juan Fita
Contact Person Email
mjuanfi81@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Onccology
Principal Investigator Name
Imanol Martinez Salas
Principal Investigator Email
Imanol.martinez@quironsalud.es
Contact Person Name
Imanol Martinez Salas
Contact Person Email
Imanol.martinez@quironsalud.es
Site Name
Institut Catala D'oncologia
Department Name
Onccology
Principal Investigator Name
Josep Maria Piulats Rodriguez
Principal Investigator Email
jmpiulats@iconcologia.net
Contact Person Name
Josep Maria Piulats Rodriguez
Contact Person Email
jmpiulats@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Onccology
Principal Investigator Name
Daniel Castellano Gauna
Principal Investigator Email
CDANICAS@HOTMAIL.COM
Contact Person Name
Daniel Castellano Gauna
Contact Person Email
CDANICAS@HOTMAIL.COM

Finland

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
523
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
HUS-Yhtymae
Principal Investigator Name
Antti Rannikko
Principal Investigator Email
antti.rannikko@hus.fi
Contact Person Name
Antti Rannikko
Contact Person Email
antti.rannikko@hus.fi
Site Name
Turku University Hospital
Principal Investigator Name
Peter Boström
Principal Investigator Email
peter.bostrom@varha.fi
Contact Person Name
Peter Boström
Contact Person Email
peter.bostrom@varha.fi
Site Name
Kuopio University Hospital
Department Name
Syöpäkeskus
Principal Investigator Name
Okko Kääriäinen
Principal Investigator Email
okko.kaariainen@pshyvinvointialue.fi
Contact Person Name
Okko Kääriäinen
Site Name
Oulu University Hospital
Department Name
Kiviharjuntie 7, F-building
Principal Investigator Name
Hanna Ronkainen
Principal Investigator Email
hanna.ronkainen@pohde.fi
Contact Person Name
Hanna Ronkainen
Contact Person Email
hanna.ronkainen@pohde.fi
Site Name
Tampere University Hospital
Department Name
Urology
Principal Investigator Name
Teemu Johannes Murtola
Principal Investigator Email
teemu.murtola@pirha.fi
Contact Person Name
Teemu Johannes Murtola
Contact Person Email
teemu.murtola@pirha.fi

Czechia

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
504
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Fakultni Thomayerova nemocnice
Principal Investigator Name
Eugen Kubala
Principal Investigator Email
eugen.kubala@ftn.cz
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Multiscan s.r.o.
Principal Investigator Name
Karel Odrážka
Principal Investigator Email
odrazka@multiscan.cz
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz
Site Name
Fakultni Nemocnice Ostrava
Principal Investigator Name
Zuzana Zděblová Čermáková
Principal Investigator Email
zuzana.zdeblova.cermakova@fno.cz
Contact Person Name
Zuzana Zděblová Čermáková
Site Name
University Hospital Olomouc
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Krajska nemocnice Liberec a.s.
Principal Investigator Name
Igor Richter
Principal Investigator Email
igor.richter@seznam.cz
Contact Person Name
Igor Richter
Contact Person Email
igor.richter@seznam.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Principal Investigator Name
Jan Dvořák
Principal Investigator Email
jan.dvorak@fnkv.cz
Contact Person Name
Jan Dvořák
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
Urocentrum Praha s.r.o.
Principal Investigator Name
Michaela Matoušková
Principal Investigator Email
matouskova@urocentrum.cz
Contact Person Name
Michaela Matoušková
Contact Person Email
matouskova@urocentrum.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
Clario
Responsibilities
Imaging - Blinded independent central review (BICR) for protocol
Name
PPD Global Clinical Labs
Name
WCG Clinical Inc.
Responsibilities
Patient Recruitment
Name
Icon (Lr) Limited
Responsibilities
Investigators trainings
Name
Innovative Trials Limited
Responsibilities
Patient Recruitment / Patient Recruitment materials
Name
Clariness GmbH
Responsibilities
Patient Recruitment
Name
Signant Health Global Solutions Limited
Responsibilities
ePRO, dosing diaries, provision of tablets to sites and mobile to patients
Name
TecEx
Responsibilities
Importer of Record and Customs clearance for ancillary supplies and materials

Third parties

  • {"country":"United States","full_name":"Clario","duties_or_roles":"Imaging - Blinded independent central review (BICR) for protocol","organisation_type":"Industry"}
  • {"country":"United States","full_name":"PPD Global Clinical Labs","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement Vendor","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Investigators trainings","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"ePRO, dosing diaries, provisions of tablets to sites and mobile to patients (if they do not use their own device)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited (additional entry)","duties_or_roles":"Patient Recruitment materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"TecEx","duties_or_roles":"Importer of Record and Customs clearance for ancillary supplies, lab kits, CD-ROMS, Investigator Site Files, Printed Materials, Patient Facing Material.","organisation_type":"Industry"}

Investigational products

Investigational Product Name
PF-06821497
Active Substance
5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
875 mg
Dose Levels
875 mg BID
Frequency
BID
Maximum Dose
1750 mg/day
Investigational Product Name
ENZALUTAMIDE
Active Substance
enzalutamide
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
160 mg
Dose Levels
160 mg QD
Frequency
QD
Maximum Dose
160 mg/day
Investigational Product Name
Tablet to match Placebo for PF-06821497 125mg / 250mg
Modality
Other
Routes Of Administration
Oral (matching tablet)
Route
ORAL
Combination Treatment
Yes

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