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
15-08-2024
First CTIS Authorization Date
10-12-2024

Trial design

Randomised, open-label, physician’s choice comparator arm (arm b): enzalutamide 160 mg qd or docetaxel 75 mg/m2 iv every 21 days (docetaxel given in combination with prednisone/prednisolone/dexamethasone; docetaxel up to a maximum of 10 cycles).-controlled Phase III trial in Slovakia, France, Hungary and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician’s choice comparator arm (Arm B): enzalutamide 160 mg QD OR docetaxel 75 mg/m2 IV every 21 days (docetaxel given in combination with prednisone/prednisolone/dexamethasone; docetaxel up to a maximum of 10 cycles).
Target Sample Size
600

Eligibility

Recruits 600 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adult males (≥18 years). Informed consent documents and country-specific ICFs are provided (see L1a_Main ICD and country-specific ICFs)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adult males (≥18 years). Informed consent documents and country-specific ICFs are provided (see L1a_Main ICD and country-specific ICFs).

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 surgical or medical castration as defined by 1 or more of the following 3 criteria:PSA progression defined as a minimum of two rising PSA levels with an interval of ≥1 week between each determination within the last 12 months. The PSA value at the Screening visit must be ≥1 ng/mL if confirmed rise in PSA is the only indication of progression per PCWG3 criteria;Soft tissue disease progression as defined by RECIST v1.1;Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan. d. Evidence of disease progression on treatment with at least 12 weeks of abiraterone acetate in the mCSPC setting or first line mCRPC setting is required. In the non-metastatic setting, evidence of disease progression during treatment (for at least 12 weeks) or within 3 months of treatment completion. In first line mCRPC, prior treatment with abiraterone acetate (for at least 12 weeks) in conjunction with olaparib or niraparib is permissible. e. Prior treatment with PARP monotherapy for BRCAm/HRRm gene mutated mCRPC following cancer progression on abiraterone acetate is not permissible.\n- 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 - 2, with life expectancy of at least 6 months as assessed by the investigator."}

Exclusion criteria

  • {"criterion_text":"- Any medical (including active or clinically significant bacterial, fungal or viral infection) 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. For eligibility assessment based upon estimated renal function, the higher of the screening and baseline eGFR values may be used.\n- Hepatic dysfunction defined as: Total bilirubin ≥1.5 × ULN; AST >2.5 × ULN; ALT >2.5 × ULN\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- Hematologic abnormalities defined as: ANC <1500/mm3; Platelets <100,000/μL; 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: 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; Cardiac rhythm device/pacemaker; QTcF >480 msec on screening ECG.\n- CNS pathology/neurological findings: Known or suspected brain metastasis or active leptomeningeal disease; Symptomatic or impending spinal cord compression or cauda equina syndrome; 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; 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: Carcinoma in situ or non-melanoma skin cancer; Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage; 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- Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (ie, 177Lu-PSMA-617, radium-223), ARSi (including enzalutamide, apalutamide, darolutamide), PARP monotherapy or other systemic anti-cancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene therapy, angiogenesis inhibitors, CDK4/6 inhibitors, 5-alpha reductase inhibitors, EZH2 inhibitors) with the following exceptions: a. Treatment with first-generation antiandrogen agents (eg, bicalutamide, nilutamide, and flutamide), but must be discontinued prior to the first dose of study medication.; b. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion; c. Current use of 5-alpha reductase inhibitors is prohibited within 28 days prior to randomization..\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 Sections 6.9.1 and 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 v1.1 (soft tissue disease) and PCWG3 (bone disease).","definition_or_measurement_approach":"BICR assessed rPFS per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease (assessed by blinded independent central review)."}

Secondary endpoints

  • {"endpoint_text":"- OS (alpha protected).","definition_or_measurement_approach":"Overall survival (OS); alpha-protected analysis as specified in protocol."}
  • {"endpoint_text":"- Proportion of participants with measurable soft tissue disease at baseline with an objective response per RECIST v1.1 (assessed by BICR).","definition_or_measurement_approach":"Objective response per RECIST v1.1 assessed by blinded independent central review (BICR) in participants with measurable soft tissue disease at baseline."}
  • {"endpoint_text":"- Duration of response in soft tissue disease per RECIST v1.1 (assessed by BICR).","definition_or_measurement_approach":"Duration of response (DoR) per RECIST v1.1 assessed by BICR."}
  • {"endpoint_text":"- Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.","definition_or_measurement_approach":"Proportion of participants achieving ≥50% PSA decline from baseline in those with detectable baseline PSA."}
  • {"endpoint_text":"- Time to PSA progression.","definition_or_measurement_approach":"Time from randomization to PSA progression as defined in protocol."}
  • {"endpoint_text":"- Time to initiation of new antineoplastic therapy.","definition_or_measurement_approach":"Time from randomization to start of any new antineoplastic therapy."}
  • {"endpoint_text":"- Time to first symptomatic skeletal event.","definition_or_measurement_approach":"Time to first symptomatic skeletal event as specified in protocol."}
  • {"endpoint_text":"- PFS2 based on investigator assessment","definition_or_measurement_approach":"PFS2 (progression-free survival on next line) based on investigator assessment."}
  • {"endpoint_text":"- Type, incidence, severity (as graded by NCI CTCAE v5.0), seriousness and relationship to study medications of AEs.","definition_or_measurement_approach":"Adverse events characterized by type, incidence, severity (NCI CTCAE v5.0), seriousness and relationship to study medication."}
  • {"endpoint_text":"- Change from baseline in patient reported pain symptoms per BPI-SF","definition_or_measurement_approach":"Change from baseline in pain symptoms measured by Brief Pain Inventory – Short Form (BPI-SF)."}
  • {"endpoint_text":"- Change from baseline in HRQoL, functioning and symptoms per FACT-P","definition_or_measurement_approach":"Change from baseline in health-related quality of life, functioning and symptoms measured by FACT-P."}
  • {"endpoint_text":"- Change from baseline in patient reported health status per EQ-5D-5L","definition_or_measurement_approach":"Change from baseline in patient-reported health status measured by EQ-5D-5L."}
  • {"endpoint_text":"- Symptomatic toxicity and the overall side effect burden as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE) and FACT-GP5","definition_or_measurement_approach":"Symptomatic toxicity and overall side effect burden assessed via PRO-CTCAE items and FACT-GP5."}
  • {"endpoint_text":"- Time to confirmatory deterioration in patient-reported pain symptoms per BPISF Item 3 “worst pain in 24 hours”","definition_or_measurement_approach":"Time to confirmatory deterioration in BPI-SF item 3 (worst pain in 24 hours)."}
  • {"endpoint_text":"- Time to definitive deterioration in patientreported HRQoL and physical well-being per FACT-P.","definition_or_measurement_approach":"Time to definitive deterioration in FACT-P measured HRQoL and physical well-being."}
  • {"endpoint_text":"- PK characterized by pre-dose trough and post-dose plasma concentrations of PF- 06821497 at selected visits.","definition_or_measurement_approach":"Pharmacokinetics characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits."}
  • {"endpoint_text":"- ctDNA burden at baseline and on study.","definition_or_measurement_approach":"Circulating tumor DNA (ctDNA) burden measured at baseline and on study."}

Recruitment

Digital Remote Recruitment
True, digital methods include programmatic pages, study pages, online programmatic advertising, search engine ads (NL), QR postcards, patient videos, and digital informed consent flipbooks; materials are country-specific (e.g., HU, DE, SE, GR, NL, FR, IT, PL, CZ, SK, ES).
Planned Sample Size
600
Recruitment Window Months
46
Consent Approach
Informed consent is obtained from the participant (adult male ≥18 years). Country-specific informed consent forms and subject information documents are provided (examples: L1a_Main ICD_C2321014_SK_SK_Public and corresponding country-specific ICFs for FR, DE, HU, SE, IT, PL, GR, CZ, NL, ES). Additional consent materials include addenda, privacy supplements, optional retained research samples consent forms, and pregnant partner release/consent forms where applicable.

Methods

  • Country-specific recruitment arrangements documented (K1 recruitment arrangements) and materials (brochures, flyers, posters, study brochure inserts) — documents available per country (e.g., HU, DE, SE, GR, NL, FR, IT, PL, CZ, SK, ES).
  • Digital recruitment: programmatic pages / study pages, QR postcards linking to study pages, online programmatic advertising and search engine advertisement text (Netherlands).
  • Patient video / patient video storyboard used for outreach.
  • Printed materials: brochures, flyers, posters and program brochures for site distribution.
  • Informed consent flipbook and patient-facing informed consent materials to support recruitment and consent discussions.
  • Retention items and modest participant incentives described (e.g., headphones, socks) as retention items.
  • Patient recruitment vendors and CRO support (WCG Clinical Inc., Innovative Trials Limited, Clariness GmbH) engaged for patient recruitment activities.

Geography

Total Number Of Sites
59
Total Number Of Participants
205

Slovakia

Earliest CTIS Part Ii Submission Date
08-11-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
35
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Oddelenie radiačnej onkológie
Contact Person Name
Pavol Dubinský
Contact Person Email
dubinsky@vou.sk
Site Name
Narodny Onkologicky Ustav
Department Name
II. Onkologická klinika LFUK a NOÚ
Contact Person Name
Michal Mego
Contact Person Email
michal.mego@nou.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
Onkologická klinika
Contact Person Name
Marián Streško
Contact Person Email
marian.stresko@fntt.sk
Site Name
Milab s.r.o.
Department Name
Urologická ambulancia
Contact Person Name
Ivan Minčík
Contact Person Email
mincik.ivan@gmail.com
Site Name
Univerzitna Nemocnica Martin
Department Name
Urologická klinika JLF UK a UNM
Contact Person Name
Ján Ľupták
Contact Person Email
jan.luptak@uniba.sk

France

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
76
Number Of Sites
13
Number Of Participants
57

Sites

Site Name
Hospital Foch
Department Name
Medical Oncology
Contact Person Name
Ratta Raffaele
Contact Person Email
r.ratta@hopital-foch.com
Site Name
Centre Oscar Lambret
Contact Person Name
Amela Yaovi Eric
Contact Person Email
ericamela@yahoo.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncology Department
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Contact Person Name
Gobert Aurélien
Contact Person Email
aurelien.gobert@icrb.fr
Site Name
Oncoradio Centre Oncogard
Department Name
Oncology Department
Contact Person Name
Nadine Houede
Contact Person Email
nadine.houede@chu-nimes.fr
Site Name
Centre Antoine Lacassagne
Contact Person Name
Borchiellini Delphine
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de cancérologie et hématologie
Contact Person Name
Auberger Benjamin
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Oncopole Claudius Regaud
Contact Person Name
Mourey Loïc
Contact Person Email
Mourey.Loic@iuct-oncopole.fr
Site Name
Centre Jean Perrin
Contact Person Name
Mahammedi Hakim
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Oncology Medical
Contact Person Name
Barthelemy Philippe
Site Name
Centre Leon Berard
Contact Person Name
Flechon Aude
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut Godinot
Contact Person Name
Eymard Jean-Christophe
Contact Person Email
jc.eymard@reims.unicancer.fr
Site Name
Institut Gustave Roussy
Contact Person Name
Macarena Rey CARDENAS

Hungary

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
49
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Onkológiai Osztály
Contact Person Name
Andras Szigeti
Contact Person Email
drszigetia.petz@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Urogenitális Tumorok és Klinikai Farmakológiai Osztály
Contact Person Name
Lajos Geczi
Contact Person Email
geczi.lajos@oncol.hu

Germany

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
29
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Universitaet Muenster
Department Name
Urology
Contact Person Name
Martin Bögemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Urology
Contact Person Name
Tilman Todenhöfer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Urologie Neandertal
Department Name
Urology
Contact Person Name
Philipp Spiegelhalder
Contact Person Email
p_spiegelhalder@web.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Urology
Contact Person Name
Steffen Rausch
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Urology
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de

Sweden

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
35
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Verksamhet onkologi, Blå Stråket 2
Contact Person Name
Jon Kindblom
Contact Person Email
Jon.Kindblom@vgregion.se
Site Name
Soedersjukhuset AB
Department Name
Onkologiska kliniken
Contact Person Name
Chunde Li
Contact Person Email
chunde.li@sll.se

Italy

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
31
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Genitourinary Medical Oncology
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 1
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it

Greece

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
99
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
Oncologic Clinical Trials and Research Clinic
Contact Person Name
Evangelos Bournakis
Contact Person Email
vagimith@yahoo.com
Site Name
Alexandra Hospital
Department Name
Oncology Department
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
Medical Oncology Department and Clinical Trials Unit
Contact Person Name
Marinos Tsiatas
Contact Person Email
tsiatas@hotmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Department of Propaedeutic and Internal Medicine
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr

Czechia

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
36
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Multiscan s.r.o.
Department Name
Oncology
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Department of Oncology
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Oncology
Contact Person Name
Jan Dvořák
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
University Hospital Olomouc
Department Name
Department of Oncology
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Netherlands

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
11
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Meander Medisch Centrum
Department Name
Oncology
Contact Person Name
Joyce van Dodewaard
Contact Person Email
jm.van.dodewaard@meandermc.nl
Site Name
Frisius MC
Department Name
Oncology
Contact Person Name
Marco Ben Polee
Contact Person Email
m.polee@frisiusmc.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Oncology
Contact Person Name
Diederik Somford
Contact Person Email
r.somford@cwz.nl
Site Name
Tergooiziekenhuizen
Department Name
Oncology
Contact Person Name
Pieter van den Berg
Contact Person Email
pvandenberg@tergooi.nl

Spain

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
31
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Enrique Gonzalez Billalabeitia
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Josep Maria Piulats Rodriguez
Contact Person Email
jmpiulats@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Contact Person Name
Imanol Martinez Salas
Contact Person Email
Imanol.martinez@quironsalud.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Jose Angel Arranz Arija
Contact Person Email
jarranza.oncomed@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Contact Person Name
Jose Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Begoña Mellado Gonzalez
Contact Person Email
bmellado@clinic.cat
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Medical Oncology
Contact Person Name
Mariona Figols Gorina
Contact Person Email
mfigols@althaia.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical Oncology
Contact Person Name
Juan Francisco Rodriguez Moreno
Contact Person Email
jfrodriguez@hmhospitales.com

Poland

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
34
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Beata Freier
Contact Person Email
beatafreier.bf@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Przemysław Adamczyk
Contact Person Email
p.adamczyk@naszlekarz.pl
Site Name
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Urszula Sadowska
Contact Person Email
u.sadowska@bieganski.org
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Contact Person Name
Renata Pacholczak-Madej
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@interia.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Signant Health Global Solutions Limited
Responsibilities
ePRO, dosing diaries, provision of tablets and mobile devices to patients
Name
WCG Clinical Inc.
Responsibilities
Patient recruitment
Name
Clario
Responsibilities
Imaging - Blinded independent central review (BICR)
Name
Innovative Trials Limited
Responsibilities
Patient recruitment and recruitment materials
Name
Icon (Lr) Limited
Responsibilities
Investigators trainings
Name
PPD Global Clinical Labs
Responsibilities
Laboratory services
Name
Clariness GmbH
Responsibilities
Patient recruitment
Name
TecEx
Responsibilities
Importer of Record and customs clearance for ancillary supplies
Name
Scout Clinical
Responsibilities
Patient reimbursement vendor

Third parties

  • {"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) coming from other PFE studies","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"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Imaging - Blinded independent central review (BICR) for protocol","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","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 States","full_name":"PPD Global Clinical Labs","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient Recruitment materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement Vendor","organisation_type":"Hospital/Clinic/Other health care facility"}

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 BID
Dose Levels
875 mg BID
Frequency
BID
Maximum Dose
1750 mg/day
Investigational Product Name
Xtandi - 40 mg soft capsules (enzalutamide)
Active Substance
ENZALUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation: EU/1/13/846/001
Starting Dose
160 mg QD
Dose Levels
160 mg QD
Frequency
QD
Maximum Dose
160 mg/day
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Starting Dose
75 mg/m2 IV every 21 days
Dose Levels
75 mg/m2 q21d (up to a maximum of 10 cycles)
Frequency
Every 21 days
Maximum Dose
75 mg/m2
Investigational Product Name
DEXAMETHASONE
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
8 mg/day
Investigational Product Name
PREDNISOLONE
Active Substance
PREDNISOLONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
5 mg/day
Combination Treatment
Yes

Related trials

Other published trials that may interest you.