Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
230
Countries
7
Sites
60
HER2-Positive, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer
To evaluate the efficacy of inavolisib in combination with Phesgo over placebo in combination with Phesgo as maintenance therapy on the basis of investigator assessed progression-free survival (PFS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Environment and Public Health [N06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Dec 2023 → ongoing
- Decision date (initial)
- 2023-06-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy
To evaluate the efficacy of inavolisib in combination with Phesgo over placebo in combination with Phesgo as maintenance therapy on the basis of investigator assessed progression-free survival (PFS)
Secondary objectives 3
- To evaluate the efficacy of inavolisib plus Phesgo compared with placebo plus Phesgo on the basis of overall survival (OS); objective response rate (ORR), duration of response (DOR), and clinical benefit rate (CBR); progression-free survival 2 (PFS2) and mean and mean changes from baseline score in function and HRQoL by cycle and between treatment arms as assessed through the use of the Functional (Role, Physical) and GHS/QoL scales of the EORTC QLQ-C30
- To evaluate the safety of inavolisib plus Phesgo compared with placebo plus Phesgo
- To characterize the pharmacokinetics of inavolisib in the inavolisib plus phesgo arm
Conditions and MedDRA coding
HER2-Positive, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 20.1 | PT | 10055113 | Breast cancer metastatic | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase III, placebo, inavolisib + Phego x placebo, metastatic and advanced breast cancer A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB IN COMBINATION WITH PHESGO VERSUS PLACEBO IN COMBINATION
WITH PHESGO AS MAINTENANCE THERAPY AFTER FIRST LINE INDUCTION THERAPY IN PARTICIPANTS WITH PIK3CA‑MUTATED HER2‑POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
|
Randomised Controlled | Double | [{"id":179484,"code":1,"name":"Subject"},{"id":179487,"code":5,"name":"Carer"},{"id":179485,"code":4,"name":"Analyst"},{"id":179483,"code":2,"name":"Investigator"},{"id":179486,"code":3,"name":"Monitor"}] | Arm A - Inavolisib plus Phesgo: Experimental arm: inavolisib 9 mg PO QD on Days 1−21 of each 21‑day cycle in combination with Phesgo subcutaneously every 3 weeks (Q3W) Arm B - Placebo plus Phesgo: Control arm: placebo tablets PO QD on Days 1−21 of each 21-day cycle in combination with Phesgo SC Q3W |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Age ≥ 18 years at the time of signing Informed Consent Form
- Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
- Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
- Confirmation of PIK3CA‑mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non‑hormonal treatment to recurrence of ≥ 6 months
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- LVEF of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Adequate hematologic and organ function prior to initiation of study treatment
- Participants are eligible to be randomized into the maintenance therapy of the study if they meet the following criteria in addition to other eligibility criteria: - Complete 4-8 cycles of induction therapy - Have achieved partial response (PR), complete response (CR), stable disease (SD), non‑CR/non‑PD per RECIST v1.1 after induction treatment
Exclusion criteria 11
- Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- Symptomatic active lung disease, including pneumonitis or interstitial lung disease
- History of or active inflammatory bowel disease or chronic diarrhea
- Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
- Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 7 months after the final dose of Phesgo
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Any history of leptomeningeal disease or carcinomatous meningitis
- Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
- Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Investigator assessed progression-free survival (PFS)
Secondary endpoints 9
- Overall survival (OS)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Clinical Benefit Rate (CBR)
- Progression-free survival 2 (PFS 2)
- Mean and mean changes from baseline score in function and HRQoL by cycle and between treatment arms as assessed through the use of the Functional (Role, Physical) and GHS/QoL scales of the EORTC QLQ-C30
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) grading scale
- Change from baseline in targeted clinical laboratory test results
- Plasma concentration of inavolisib at specified timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Phesgo 1200 mg/600 mg solution for injection
PRD8600161 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 38.4 g gram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Phesgo 600 mg/600 mg solution for injection
PRD8601830 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 38.4 g gram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9793130 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 4.32 g gram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793811 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 4.32 g gram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9793132 · Product
- Active substance
- Inavolisib
- Other product name
- GDC-0077
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9 mg milligram(s)
- Max total dose
- 4.32 g gram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 8
SUB02400MIG · Substance
- Active substance
- Goserelin Acetate
- Pharmaceutical form
- IMPLANT IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 17.3 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1.6 gm/m2 gram(s)/square meter
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 52.5 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07492MIG · Substance
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 525 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05502MIG · Substance
- Active substance
- Anastrozole
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 21 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB22289 · Substance
- Active substance
- Anhydrous Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2.1 gm/m2 gram(s)/square meter
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10825MIG · Substance
- Active substance
- Tamoxifen
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 260 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5.4 gm/m2 gram(s)/square meter
- Max treatment duration
- 16 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel Town
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 14
| Organisation | City, country | Duties |
|---|---|---|
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| DrugDev Inc. ORL-000000775
|
United States | Other |
| Cellcarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Labcorp Mobile Clinical Services ORL-000000777
|
Barcelona, Spain | Other |
| Icon Development Solutions LLC ORG-100012400
|
Hanover, United States | Laboratory analysis |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Teckro Limited ORG-100041454
|
Limerick, Ireland | Other |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
Locations
7 EU/EEA countries · 60 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 8 | 15 |
| Finland | Ended | 3 | 3 |
| France | Ongoing, recruiting | 12 | 5 |
| Germany | Ongoing, recruiting | 12 | 11 |
| Italy | Ongoing, recruiting | 10 | 10 |
| Poland | Ongoing, recruiting | 10 | 8 |
| Spain | Ongoing, recruiting | 12 | 8 |
| Rest of world
Mexico, Taiwan, China, Argentina, Singapore, United States, Australia, Kenya, Canada, Uganda, United Kingdom, Hong Kong, India, Turkey, Colombia, Brazil, South Africa, Korea, Republic of
|
— | 163 | — |
Investigational sites
AZ Sint-Lucas & Volkskliniek
Medical Oncology, Groenebriel 1, 9000, Gent
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
Grand Hopital De Charleroi
Oncology, Grand'rue 3, 6000, Charleroi
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Centre Hospitalier Regional De La Citadelle
Oncology, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Centre hospitalier universitaire de Liege
Oncology, Avenue De L'Hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU Helora
Medical Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Algemeen Ziekenhuis Klina
Medical Oncology, Augustijnslei 100, 2930, Brasschaat
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Oncology, Arthur Van Gehuchtenplein 4, 1020, Brussels
CHU Helora
Oncology, Boulevard President Kennedy 2, 7000, Mons
CHR Verviers
Oncology, Rue Du Parc 29, 4800, Verviers
CHU UCL Namur
Oncology, Place Louise Godin 15, 5000, Namur
Chirec
Oncology, Boulevard Du Triomphe 201, 1160, Brussels
Vaasa Central Hospital
Onchology, Hietalahdenkatu 2-4, 65130, Vaasa
Turku University Hospital
Onchology, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
Oncology, Teiskontie 35, 33520, Tampere
Centre Oscar Lambret
Oncologie Medicale, 3 Rue Frederic Combemale, 59000, Lille
Centr Georges Francois Leclerc
Service Oncologie, 1 Rue Professeur Marion, 21000, Dijon
Polyclinique Bordeaux Nord Aquitaine
Service Oncologie, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Institut Sainte Catherine
Service Oncologie, 250 Chemin De Baigne Pieds, 84000, Avignon
Centre Hospitalier De La Cote Basque
Service Oncologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Medizinisches Versorgungszentrum MediaVita GmbH Muenster
Studienzentrale der Onkologischen Zentren, Haus B, Etage 5, Hohenzollernring 70, Herz-Jesu, Muenster
Gynonco Duesseldorf
Zentrum für Gynäkologische Onkologie, MVZ Medical Center Düsseldorf GmbH, Luise-Rainer-Strasse 6-10, Flingern Nord, Duesseldorf
Caritas Tragergesellschaft Saarbruecken mbH (cts)
Brustzentrum sowie Gynäkologisches Krebszentrum, Rheinstrasse 2, Malstatt, Saarbruecken
Universitaetsklinikum Erlangen AöR
Frauenklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Klinikum St Marien Amberg
Klinik für Frauenheilkunde und Geburtshilfe, Mariahilfbergweg 7, 92224, Amberg
Klinikum Der Universitat Munchen AöR
LMU Brustzentrum, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Praxis für interdisziplinäre Onkologie & Hämatologie, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
HELIOS Klinikum Berlin-Buch GmbH
Geburtshilfe und Gynäkologie, Schwanebecker Chaussee 50, Buch, Berlin
Universitaetsklinikum Ulm AöR
Klinik für Frauenheilkunde und Geburtshilfe, Prittwitzstrasse 43, Mitte, Ulm
Dr. Apel Medizinische Versorgung GmbH
Medizinische Versorgungs GmbH, Bahnhofstrasse 46, Erfurt-Altstadt, Erfurt
Knappschaft Kliniken Bottrop GmbH
Marienhospital Bottrop; Klinik für Gynäkologie und Geburtshilfe, Josef-Albers-Strasse 70, Sued-West-Innenstadt, Bottrop
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia, Via Giacomo Venezian 1, 20133, Milan
La Maddalena S.p.A.
Oncologia Medica, Via San Lorenzo 312d, 90146, Palermo
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
European Institute Of Oncology S.r.l.
Oncologia, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda USL Toscana Centro
Oncologia Medica, Via Dell' Antella 58, 50012, Bagno A Ripoli
Azienda Ospedaliera Universitaria Integrata Verona
Oncologia, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Socio Sanitaria Territoriale Di Monza
Centro Ricerca Fase 1, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera S Giovanni Addolorata
Oncologia, Via Dell' Amba Aradam 9, 00184, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Centrum Diagnostyki i Leczenia Chorób Piersi, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Centrum Onkologii Im Prof Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii I, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Ul. Garbary 15, 61-866, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
Przychodnia Lekarska "KOMED" Roman Karaszewski, Ul. Wojska Polskiego 6, 62-500, Konin
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii Klinicznej, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-12-22 | 2024-07-23 | |||
| Finland | 2024-01-29 | 2026-03-04 | 2024-10-17 | 2026-03-04 | |
| France | 2024-05-07 | 2024-05-22 | |||
| Germany | 2024-02-02 | 2024-02-05 | |||
| Italy | 2024-04-12 | 2024-04-22 | |||
| Poland | 2024-03-28 | 2024-04-26 | |||
| Spain | 2024-01-26 | 2024-01-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 173 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502046-28-00 Redacted | 3 |
| Protocol (for publication) | D1_Protocol clarification letter 2022-502046-28-00_Redacted | N/A |
| Protocol (for publication) | D1_Protocol Clarification Letter_ENG_2022-502046-28-00_Redacted | 1 |
| Protocol (for publication) | D1_Protocol Memo 2022-502046-28-00 | N/A |
| Protocol (for publication) | D4_Patient facing documents _Glucose diary_BE_EN | 2 |
| Protocol (for publication) | D4_Patient facing documents _Glucose diary_BE_FR | 2 |
| Protocol (for publication) | D4_Patient facing documents _Glucose diary_BE_NL | 2 |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_BE_EN | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_BE_FR | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_BE_NL | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_DE | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_EN | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_ES | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_FR | n/a |
| Protocol (for publication) | D4_Patient facing documents_BPI-SF_IT | n/a |
| Protocol (for publication) | D4_Patient facing documents_BR23 BE_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23 BE_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23 BE_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_BR23_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE BE_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE BE_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE BE_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_BE_FR | n/a |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_BE_NL | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_DE | n/a |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_EN | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_ES | n/a |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_FR | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_IT | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Glucose diary_DE | 2 |
| Protocol (for publication) | D4_Patient facing documents_Glucose Diary_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_Glucose Diary_ES | 2 |
| Protocol (for publication) | D4_Patient facing documents_Glucose diary_FR | 2 |
| Protocol (for publication) | D4_Patient facing documents_Glucose Diary_IT | 2 |
| Protocol (for publication) | D4_Patient facing documents_GP5_DE | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_DUT_BE_EN | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_DUT_BE_FR | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_DUT_BE_NL | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_EN | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_ES | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_FR | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_IT | 4 |
| Protocol (for publication) | D4_Patient facing documents_IL303_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL303_ENG | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL303_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL303_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL303_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_IL303C_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Label for V2 Glucose Diary p2 EU_EN | 2 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30 BE_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30 BE_FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30 BE_NL | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_ES | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_IT | 3 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Diary_BE_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Diary_BE_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Diary_BE_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study medication diary_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Diary_EN | 2 |
| Protocol (for publication) | D4_Patient facing documents_Study medication diary_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study medication diary_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Diary_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_BE_EN | 2 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_BE_FR | 2.2 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_BE_NL | 2.2 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_DE | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_EN | 2 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_ES | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_FR | 2.2 |
| Protocol (for publication) | D4_Patient facing documents_WPAI_IT | 2.3 |
| Protocol (for publication) | D4_Pt facing documents _Glucose diary_BE_Dutch | 1 |
| Recruitment arrangements (for publication) | K1_2022-502046-28_Recruitment and ICF procedure_WO44263 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_WO44263 | 3 |
| Recruitment arrangements (for publication) | K1_WO44263_DEU_Recruitment and Informed Consent Procedure | 3 |
| Recruitment arrangements (for publication) | K2_ recruitment Przewodnik po badaniu_REDACTED | 2 |
| Recruitment arrangements (for publication) | K2_Document additionel_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_recruitment material Biomarker Leaflet REDACTED | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material biomarker leaflet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material patient information flyer_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Template Communication To Doctors_REDACTED | 1 |
| Recruitment arrangements (for publication) | L2_Other subject information material_Biomarker leaflet_WO44263 | 1 |
| Recruitment arrangements (for publication) | L2_Other subject information material_Study visit guide_WO44263 | 2 |
| Recruitment arrangements (for publication) | L2_WO44263_DEU_Social Media Posts | 1 |
| Subject information and informed consent form (for publication) | L1_2022-502046-28_NICF_Principal_redacted_W044263 | 1 |
| Subject information and informed consent form (for publication) | L1_2022-502046-28_Recruitment and ICF procedure_WO44263 | 2 |
| Subject information and informed consent form (for publication) | L1_General Pratictioner Letter_File Note | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF biomarker screening | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Screening ICF_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Screening ICF_EN | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Screening ICF_FR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Screening ICF_NL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker Screening ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire Reimbursement Information Sheet_EN | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire Reimbursement Information Sheet_FR | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire Reimbursement Information Sheet_NL | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF infant authorization form | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form ICF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form ICF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization Form ICF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Lay CTD_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_EN_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_FR_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_NL_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main study_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_WO44263_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile nursing | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing ICF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OptionalBiopsy ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA ICF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PregnantPartner ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy subject other than patient | 11Nov2024 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Authorization for the use and sharing of Infant Health Information | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Authorization for the use and sharing of Pregnancy Health info | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biomarker Screening | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biomarker Screening | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Authorization Form | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Informed Consent Form -Clean | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Collection and-or storage of sample | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Mobile Nursing | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Tumor Biopsy_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Information and Informed Consent Form_REDACTED | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR Biomarker Screening | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_Additional information leaflet | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Data Privacy Information Sheet_Appendix 1 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_Biopsia opcional_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_home nursing | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_IAF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_PPA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_RBR Biomarker | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF WO44263_RBR general | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_ WO44263_General_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_WO44263 _ Biomarker Screening_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_WO44263_DEU_ICF_opt Biopsies_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_WO44263_DEU_ICF_Prescreen_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_WO44263_DEU_ICF_RBR_redacted | 3 |
| Subject information and informed consent form (for publication) | L2_INAVO122_Biomarker leaflet_Spanish_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_INAVO122_Patient information flyer_Spanish_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Form Procedure | 1 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use Of ICF Model | 1 |
| Subject information and informed consent form (for publication) | L2_Study visits guide_redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2022-502046-28-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-502046-28-00 | 1 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-16 | Germany | Acceptable 2023-06-28
|
2023-06-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-11 | Acceptable 2023-06-28
|
2023-07-11 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-06 | Germany | Acceptable 2024-01-19
|
2024-01-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-14 | Germany | Acceptable 2024-05-28
|
2024-05-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-07 | Germany | Acceptable 2024-05-28
|
2024-06-07 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-06-21 | Germany | Acceptable 2024-05-28
|
2024-06-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-30 | Acceptable | 2024-09-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-02 | Acceptable | 2024-10-05 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-02 | Acceptable | 2024-10-15 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-07 | Acceptable | 2024-09-19 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-20 | Germany | Acceptable 2025-02-19
|
2025-02-20 |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-19 | Germany | Acceptable 2025-05-30
|
2025-05-30 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-28 | Germany | Acceptable 2025-05-30
|
2025-07-28 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-08-08 | Acceptable 2025-05-30
|
2025-08-08 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-02 | Germany | Acceptable 2025-10-22
|
2025-10-22 |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-12-12 | Acceptable | 2026-02-06 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-12 | Acceptable | 2026-01-26 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-02-24 | Germany | Acceptable | 2026-02-24 |
| 19 | SUBSTANTIAL MODIFICATION | SM-15 | 2026-03-20 | Germany | Acceptable 2026-05-26
|
2026-05-28 |