Clinical trial • Oncology

ENTRECTINIB for Cancer

Clinical trial of ENTRECTINIB for Cancer. open-label. 254 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Cancer
Drug Modality
Small molecule|Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
16-11-2023
First CTIS Authorization Date
08-01-2024

Trial design

open-label trial in Belgium, France, Poland and others.

Open Label
Yes
Target Sample Size
254

Eligibility

Recruits 254 paediatric patients.

Pregnancy Exclusion
4. Negative urine pregnancy test within 24 hours prior to first dose administered on BX44273 study treatment in female participants of childbearing potential
Vulnerable Population
Vulnerable populations have been selected. The dossier includes age-specific informed consent/assent materials (e.g. L1_SIS and ICF_Entrectinib_3-7 years; L1_SIS and ICF_Entrectinib_7-13 years; L1_SIS and ICF_Entrectinib_13-18 years) and infant authorization forms and partner/pregnant-partner authorization forms, indicating procedures for consent from parents/guardians and assent for minors and specific authorization for infants.

Inclusion criteria

  • {"criterion_text":"- 1. Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol or Eligible for continuing the comparator agent(s) in a Genentech- or Rochesponsored study as per the parent study protocol, with no access to commercially available comparator agent\n- 2. First dose of study treatment in this extension study will be received within 7days of the treatment interruption window allowed by the parent study\n- 3. Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator, in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression after an integrated assessment of radiographic data, biopsy results (if available) and clinical status.\n- 4. Negative urine pregnancy test within 24 hours prior to first dose administered on BX44273 study treatment in female participants of childbearing potential\n- 5. Ability to comply with the extension study protocol, per Investigator's judgement"}

Exclusion criteria

  • {"criterion_text":"- 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study\n- 2. Study treatment or comparator agent is commercially marketed in the participant’s country for the participant-specific disease and is accessible to the participant\n- 3. Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study\n- 4. Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)\n- 5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤ 1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study\n- 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatmentrelated complications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Number of Participants with Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. The incidence, nature, and severity of selected adverse events as described in IMP-specific appendices","definition_or_measurement_approach":"As described in IMP-specific appendices (incidence, nature and severity of selected adverse events)"}

Recruitment

Planned Sample Size
254
Recruitment Window Months
118
Consent Approach
Informed consent is obtained using subject information and informed consent forms; age-specific ICFs and assent/authorization forms are provided (including infant authorization forms and age-group ICFs for 3-7, 7-13, 13-18 years). ICFs are available in multiple languages (examples in the dossier: English, French, Dutch, Polish, Greek). Pregnant partner authorization forms are included where applicable.

Geography

Total Number Of Sites
21
Total Number Of Participants
23

Belgium

Earliest CTIS Part Ii Submission Date
24-02-2023
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
1124
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Oncology
Principal Investigator Name
David Schroder
Principal Investigator Email
david.schroder@ghdc.be
Contact Person Name
David Schroder
Contact Person Email
david.schroder@ghdc.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Urology
Principal Investigator Name
Siska Van Bruwaene
Principal Investigator Email
siska.vanbruwaene@azgroeninge.be
Contact Person Name
Siska Van Bruwaene
Site Name
UZ Leuven
Department Name
Oncology
Principal Investigator Name
Sabine Tejpar
Principal Investigator Email
sabine.tejpar@uzleuven.be
Contact Person Name
Sabine Tejpar
Contact Person Email
sabine.tejpar@uzleuven.be

France

Earliest CTIS Part Ii Submission Date
24-02-2023
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
1148
Number Of Sites
12
Number Of Participants
14

Sites

Site Name
Institut Curie
Department Name
Oncology
Principal Investigator Name
Edith Borcoman
Principal Investigator Email
guichet.investigation@curie.fr
Contact Person Name
Edith Borcoman
Contact Person Email
guichet.investigation@curie.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncology
Principal Investigator Name
Jacques Cadranel
Principal Investigator Email
jacques.cadranel@aphp.fr
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Principal Investigator Name
Jean-Pierre Delord
Principal Investigator Email
delord.jean-pierre@iuct-oncopole.fr
Contact Person Name
Jean-Pierre Delord
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncology
Principal Investigator Name
Laurent Greillier
Principal Investigator Email
cepcm@ap-hm.fr
Contact Person Name
Laurent Greillier
Contact Person Email
cepcm@ap-hm.fr
Site Name
Centre Francois Baclesse
Department Name
Oncology
Principal Investigator Name
Florence Joly
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Oncology
Principal Investigator Name
Patricia Pautier
Principal Investigator Email
patricia.pautier@gustaveroussy.fr
Contact Person Name
Patricia Pautier
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Véronique D'HONDT
Principal Investigator Email
icm@icm.unicancer.fr
Contact Person Name
Véronique D'HONDT
Contact Person Email
icm@icm.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Principal Investigator Name
Dominique BERTON
Principal Investigator Email
dominique.berton-rigaud@ico.unicancer.fr
Contact Person Name
Dominique BERTON
Site Name
Institut De Cancerologie De Bourgogne
Department Name
Oncology
Principal Investigator Name
Véronique LORGIS
Principal Investigator Email
secretaires-dijon@icb-cancer.fr
Contact Person Name
Véronique LORGIS
Site Name
Centre Hospitalier Saint Joseph Saint Luc
Department Name
Oncology
Principal Investigator Name
Isabelle Ray Coquard
Principal Investigator Email
isabelle.ray-coquard@lyon.unicancer.fr
Contact Person Name
Isabelle Ray Coquard
Site Name
Institut Bergonie
Department Name
Oncology
Principal Investigator Name
Sophie Cousin
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Medical Oncology
Principal Investigator Name
Nadine Houédé
Principal Investigator Email
nadine.houede@chu-nimes.fr
Contact Person Name
Nadine Houédé
Contact Person Email
nadine.houede@chu-nimes.fr

Poland

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
807
Number Of Sites
4
Number Of Participants
1

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Principal Investigator Name
Rafał Dziadziuszko
Principal Investigator Email
nszmukala@uck.gda.pl
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
nszmukala@uck.gda.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Poznań
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
md.piotr.tomczak@gmail.com
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
Principal Investigator Name
Tomasz Świtaj
Principal Investigator Email
miesaki@nio.gov.pl
Contact Person Name
Tomasz Świtaj
Contact Person Email
miesaki@nio.gov.pl

Greece

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
374
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
Oncology Clinical Trials & Research Clinic
Principal Investigator Name
Evangelos Bournakis
Principal Investigator Email
vagimith@yahoo.com
Contact Person Name
Evangelos Bournakis
Contact Person Email
vagimith@yahoo.com

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Global CRO
Name
Almac Clinical Technologies LLC
Responsibilities
sponsor duty code:3

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Rozlytrek 200 mg hard capsules
Active Substance
ENTRECTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation: EU/1/20/1460/002
Maximum Dose
600 mg
Investigational Product Name
RO7538483
Active Substance
ATEZOLIZUMAB, TIRAGOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Ipatasertib
Active Substance
IPATASERTIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
400 mg
Investigational Product Name
INAVOLISIB
Active Substance
INAVOLISIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
9 mg
Investigational Product Name
RO 743-5846 (Divarasib)
Active Substance
DIVARASIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Avastin 25 mg/ml concentrate for solution for infusion.
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation: EU/1/04/300/002
Maximum Dose
15 mg/Kg
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation: EU/1/17/1220/001
Maximum Dose
1875 mg
Investigational Product Name
Tiragolumab
Active Substance
TIRAGOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Maximum Dose
600 mg
Investigational Product Name
ABIRATERONE
Active Substance
ABIRATERONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1000 mg
Combination Treatment
Yes

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