Clinical trial • Phase II • Oncology

BEVACIZUMAB for Advanced ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Phase II trial of BEVACIZUMAB for Advanced ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer. CTIS 2021-004278-76.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Trial Stage
Phase II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
07-05-2024
First CTIS Authorization Date
25-06-2024

Trial design

Randomised, arm a: paclitaxel 175 mg/m² + carboplatin auc 5-6 followed by maintenance niraparib (dose/schedule not specified in json). arm b: paclitaxel 175 mg/m² + carboplatin auc 5-6 + bevacizumab (15 mg/kg every 3 weeks, started at second chemotherapy cycle, up to total 15 months) followed by maintenance niraparib + bevacizumab.-controlled Phase II trial in France, Italy, Spain and others.

Randomised
Yes
Comparator
Arm A: Paclitaxel 175 mg/m² + Carboplatin AUC 5-6 followed by maintenance Niraparib (dose/schedule not specified in JSON). Arm B: Paclitaxel 175 mg/m² + Carboplatin AUC 5-6 + Bevacizumab (15 mg/kg every 3 weeks, started at second chemotherapy cycle, up to total 15 months) followed by maintenance Niraparib + Bevacizumab.
Target Sample Size
336

Eligibility

Recruits 336 Signed informed consent required from participant; no vulnerable populations selected; only adult females ≥ 18 years; assent not applicable..

Pregnancy Exclusion
Pregnant or lactating women.
Vulnerable Population
Signed informed consent required from participant; no vulnerable populations selected; only adult females ≥ 18 years; assent not applicable.

Inclusion criteria

  • {"criterion_text":"- Female patient ≥ 18 years of age.\n- Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months.\n- Patient must have normal organ and bone marrow function before first cycle of chemotherapy: • Hemoglobin ≥ 9.0 g/dL. • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. • Platelet count ≥ 100 x 109/L. • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). • Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN. • Serum creatinine ≤ 1. 5 x institutional ULN and GFR > 50 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator’s discretion. GINECO-OV129b / ENGOT-OV63 / EUDRACT 2021-004278-76 – NIRVANA-1 – Protocol - Version 2.0 – 30/03/2022 (From FORM 113-02 : Protocol – Application date : 22/JUN/2020) Page 7 on 96 • Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≥1.5 and a Partial Thromboplastin Time (PTT) or an activated PTT (aPTT) ≥1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or the PTT or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.\n- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be <1 g.\n- Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).\n- Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional).\n- For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of a social security category.\n- Signed informed consent and ability to comply with treatment and follow-up.\n- Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or GINECO-OV129b / ENGOT-OV63 / EUDRACT 2021-004278-76 – NIRVANA-1 – Protocol - Version 2.0 – 30/03/2022 (From FORM 113-02 : Protocol – Application date : 22/JUN/2020) Page 6 on 96 fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings): • high grade serous or • high grade endometrioid (grade 2 and 3) or • other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.\n- Patient having undergone frontline, complete cytoreductive surgery (i.e. no visible residual disease): The patient will be considered eligible once the ESGO Quality Assurance in Ovarian Cancer Surgery will have been filled out and validated\n- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n- Patient must have received one cycle of carboplatin AUC 5-6 + paclitaxel 175 mg/m²\n- Patient must have started cycle 1 chemotherapy no later than 6 weeks after surgery.\n- Patient must have a thorax-abdomen-pelvis CT scan or MRI between surgery and Cycle 1, with no evidence of disease.\n- Patient eligible for first line platinum-taxane chemotherapy:"}

Exclusion criteria

  • {"criterion_text":"- Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors).\n- Significant traumatic injury during 4 weeks prior to randomization.\n- Non-healing wound, active ulcer, or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations.\n- Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma.\n- History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.\n- Current, clinically relevant bowel obstruction, including sub- occlusive disease, related to underlying disease.\n- Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.\n- Pregnant or lactating women.\n- Participation in another clinical study with any intravenous or oral investigational product is not allowed. However, participation in a surgical clinical study including Hyperthermic Chemotherapy (HIPEC) during the surgical procedure is allowed.\n- Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication.\n- Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.\n- Patient with a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, or their excipients.\n- Immunocompromised patient.\n- Patient with active viral infection (Hepatitis B or C and/or Human Immunodeficiency Virus).\n- Patient with a diagnosis, detection, or treatment of another type of cancer ≤ 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated and synchronous grade 1 stage 1 endometrial cancer) Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.\n- Participant has a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n- Patient with synchronous high grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.\n- Patient with myelodysplastic syndrome/acute myeloid leukemia history.\n- Patient receiving radiotherapy within 6 weeks prior to study treatment.\n- Previous allogenic bone marrow transplant\n- Any previous treatment with PARP inhibitor.\n- Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.\n- Administration of other simultaneous chemotherapy drugs – except during a HIPEC procedure with cisplatin at PDS, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroid antiemetics).\n- History of Posterior Reversible Encephalopathy Syndrome (PRES).\n- Clinically significant (e.g. active) cardiovascular disease, including: • Myocardial infarction or unstable angina within ≤ 6 months of randomization, • New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF), • Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG. • Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision).\n- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA), Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.\n- History or evidence of hemorrhagic disorders within 6 months prior to randomization.\n- Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).\n- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.\n- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first.","definition_or_measurement_approach":"Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression Free Survival 2 (PFS2)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Safety (assessed based on CTCAE version 5)","definition_or_measurement_approach":"Safety assessed based on CTCAE version 5"}
  • {"endpoint_text":"- Time to First Subsequent Treatment (TFST)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to Second Subsequent Treatment (TSST)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS) at 5 years","definition_or_measurement_approach":"Overall survival measured at 5 years"}
  • {"endpoint_text":"- Confirm the predictive value (overall chemo-sensitivity) of the KELIM (CA-125 Elimination rate constant K)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
336
Recruitment Window Months
120
Consent Approach
Signed informed consent required from adult participant (participant must be ≥ 18). ICFs and subject information materials available in multiple language versions (documents include French, Spanish, English and Dutch versions as per uploaded ICF and SIS documents). No assent procedure (adult-only).

Geography

Total Number Of Sites
70
Total Number Of Participants
336

France

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
672
Number Of Sites
44
Number Of Participants
211

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'oncologie médicale
Principal Investigator Name
Séphane OUDARD
Principal Investigator Email
stephane.oudard@aphp.fr
Contact Person Name
Séphane OUDARD
Contact Person Email
stephane.oudard@aphp.fr
Site Name
Centre Hospitalier De Cholet
Department Name
Service d'oncologie médicale
Principal Investigator Name
Victor SIMMET
Principal Investigator Email
victor.simmet@ch-cholet.fr
Contact Person Name
Victor SIMMET
Contact Person Email
victor.simmet@ch-cholet.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service d'oncologie médicale
Principal Investigator Name
Laura DEIANA
Principal Investigator Email
laura.deiana@chu-brest.fr
Contact Person Name
Laura DEIANA
Contact Person Email
laura.deiana@chu-brest.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Service d'oncologie médicale
Principal Investigator Name
Alain LORTHOLARY
Principal Investigator Email
alain.lortholary@groupeconfluent.fr
Contact Person Name
Alain LORTHOLARY
Site Name
Centre Oscar Lambret
Department Name
Canc. Chir. Gyn., Pavillon Paul Gellé
Principal Investigator Name
Valérie CHEVALIER-EVAIN
Principal Investigator Email
v-chevalier@o-lambret.fr
Contact Person Name
Valérie CHEVALIER-EVAIN
Contact Person Email
v-chevalier@o-lambret.fr
Site Name
Hopital Tenon
Department Name
Service d'oncologie médicale
Principal Investigator Name
Marc-Antoine BENDERRA
Principal Investigator Email
marc-antoine.benderra@aphp.fr
Contact Person Name
Marc-Antoine BENDERRA
Contact Person Email
marc-antoine.benderra@aphp.fr
Site Name
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Department Name
Service d'oncologie médicale
Principal Investigator Name
Elise BONNET
Principal Investigator Email
elise.bonnet@avec.fr
Contact Person Name
Elise BONNET
Contact Person Email
elise.bonnet@avec.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service d'oncologie médicale
Principal Investigator Name
Marie-Agnes BY
Principal Investigator Email
ma.by@chu-tours.fr
Contact Person Name
Marie-Agnes BY
Contact Person Email
ma.by@chu-tours.fr
Site Name
Besancon University Hospital Center
Department Name
Service d'oncologie médicale
Principal Investigator Name
Laura MANSI
Principal Investigator Email
lmansi@chu-besancon.fr
Contact Person Name
Laura MANSI
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d'oncologie médicale
Principal Investigator Name
Gilles Freyer
Principal Investigator Email
gilles.freyer@chu-lyon.fr
Contact Person Name
Gilles Freyer
Contact Person Email
gilles.freyer@chu-lyon.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service d'oncologie médicale
Principal Investigator Name
Dominique BERTON
Principal Investigator Email
dominique.berton@ico.unicancer.fr
Contact Person Name
Dominique BERTON
Site Name
Institut Claudius Regaud
Department Name
Service d'oncologie médicale
Principal Investigator Name
Laurence GLADIEFF
Principal Investigator Email
gladieff.laurence@iuct-oncopole.fr
Contact Person Name
Laurence GLADIEFF
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Service d'oncologie médicale
Principal Investigator Name
Sophie ABADIE-LACOURTOISIE
Contact Person Name
Sophie ABADIE-LACOURTOISIE
Site Name
Clinique Victor Hugo
Department Name
Service d'oncologie médicale
Principal Investigator Name
Sphie ROCHE
Principal Investigator Email
essaisroche@ilcgroupe.fr
Contact Person Name
Sphie ROCHE
Contact Person Email
essaisroche@ilcgroupe.fr
Site Name
Centre Leon Berard
Department Name
Service d'oncologie médicale
Principal Investigator Name
Isabelle RAY-COQUARD
Principal Investigator Email
isabelle.ray-coquard@lyon.unicancer.fr
Contact Person Name
Isabelle RAY-COQUARD
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Service d'oncologie médicale
Principal Investigator Name
Nicolas DELANOY
Principal Investigator Email
ndelanoy@ghpsj.fr
Contact Person Name
Nicolas DELANOY
Contact Person Email
ndelanoy@ghpsj.fr
Site Name
Institut Mutualiste Montsouris
Department Name
Service d'oncologie médicale
Principal Investigator Name
Marie-Liesse JOULIA
Principal Investigator Email
Marie-Liesse.Joulia@imm.fr
Contact Person Name
Marie-Liesse JOULIA
Contact Person Email
Marie-Liesse.Joulia@imm.fr
Site Name
Centre Azuréen de Cancérologie
Department Name
Service d'oncologie médicale
Principal Investigator Name
Remy LARGILLIER
Principal Investigator Email
r.largillier@cac-mougins.fr
Contact Person Name
Remy LARGILLIER
Contact Person Email
r.largillier@cac-mougins.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Service d'oncologie médicale
Principal Investigator Name
Olfa DERBEL
Principal Investigator Email
o.derbelmermoz@gmail.com
Contact Person Name
Olfa DERBEL
Contact Person Email
o.derbelmermoz@gmail.com
Site Name
Institut Bergonie
Department Name
Service d'oncologie médicale
Principal Investigator Name
Coriolan LEBRETON
Principal Investigator Email
c.lebreton@bordeaux.unicancer.fr
Contact Person Name
Coriolan LEBRETON
Site Name
Centre Henri Becquerel
Department Name
Service d'oncologie médicale
Principal Investigator Name
Camille PETRAU
Principal Investigator Email
camille.petrau@chb.unicancer.fr
Contact Person Name
Camille PETRAU
Site Name
Hopital De La Croix Rousse
Department Name
Service d'oncologie médicale
Principal Investigator Name
Gilles Freyer
Principal Investigator Email
gilles.freyer@univ-lyon1.fr
Contact Person Name
Gilles Freyer
Contact Person Email
gilles.freyer@univ-lyon1.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d'oncologie médicale
Principal Investigator Name
Coralie FRENOUX
Principal Investigator Email
cfrenoux@chu-grenoble.fr
Contact Person Name
Coralie FRENOUX
Contact Person Email
cfrenoux@chu-grenoble.fr
Site Name
Clinique Tivoli
Department Name
Service d'oncologie médicale
Principal Investigator Name
Pauline REGNAULT DE LA MOTHE
Principal Investigator Email
p.regnault@tivoli-oncologie.fr
Contact Person Name
Pauline REGNAULT DE LA MOTHE
Contact Person Email
p.regnault@tivoli-oncologie.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Service d'oncologie médicale
Principal Investigator Name
Hervé FOKA-TICHOUE
Principal Investigator Email
herve.fokatichoue@aphp.fr
Contact Person Name
Hervé FOKA-TICHOUE
Contact Person Email
herve.fokatichoue@aphp.fr
Site Name
Institut Sainte Catherine
Department Name
Service d'oncologie médicale
Principal Investigator Name
Julien GRENIER
Principal Investigator Email
j.grenier@isc84.org
Contact Person Name
Julien GRENIER
Contact Person Email
j.grenier@isc84.org
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service d'oncologie médicale
Principal Investigator Name
Delphine DULIEGE
Principal Investigator Email
Delphine.DULIEGE@chu-nimes.fr
Contact Person Name
Delphine DULIEGE
Contact Person Email
Delphine.DULIEGE@chu-nimes.fr
Site Name
Centre Hospitalier Valence
Department Name
Service d'oncologie médicale
Principal Investigator Name
Rim BATTI
Principal Investigator Email
rbatti@ch-valence.fr
Contact Person Name
Rim BATTI
Contact Person Email
rbatti@ch-valence.fr
Site Name
Hospital Femme Mere Enfant
Department Name
Service d'oncologie médicale
Principal Investigator Name
Gilles FREYER
Principal Investigator Email
gilles.freyer@univ-lyon1.fr
Contact Person Name
Gilles FREYER
Contact Person Email
gilles.freyer@univ-lyon1.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service d'oncologie médicale
Principal Investigator Name
Gilles FREYER
Principal Investigator Email
gilles.freyer@chu-st-etienne.fr
Contact Person Name
Gilles FREYER
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Service d'oncologie médicale
Principal Investigator Name
Véronique D'HONDT
Principal Investigator Email
veronique.dhondt@icm.unicancer.fr
Contact Person Name
Véronique D'HONDT
Site Name
Assistance Publique Hopitaux De Paris (27 Rue Du Faubourg Saint Jacques)
Department Name
Service d'oncologie médicale
Principal Investigator Name
Jérôme ALEXANDRE
Principal Investigator Email
jerome.alexandre@aphp.fr
Contact Person Name
Jérôme ALEXANDRE
Contact Person Email
jerome.alexandre@aphp.fr
Site Name
Groupe hospitalier Diaconesses Croix Saint Simon
Department Name
Service d'oncologie médicale
Principal Investigator Name
Frédéric SELLE
Principal Investigator Email
fselle@hopital-dcss.org
Contact Person Name
Frédéric SELLE
Contact Person Email
fselle@hopital-dcss.org
Site Name
Centre Hospitalier Universitaire De Montpellier (80 Avenue Augustin Fliche)
Department Name
Service d'oncologie médicale
Principal Investigator Name
Clothilde LINDET-BOURGEOIS
Principal Investigator Email
c-lindetbourgeois@chu-montpellier.fr
Contact Person Name
Clothilde LINDET-BOURGEOIS
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service d'oncologie médicale
Principal Investigator Name
Thibault DE LA MOTTE ROUGE
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault DE LA MOTTE ROUGE
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'oncologie médicale
Principal Investigator Name
Sheik ENAMBUX
Principal Investigator Email
sheik.emambux@chu-poitiers.fr
Contact Person Name
Sheik ENAMBUX
Contact Person Email
sheik.emambux@chu-poitiers.fr
Site Name
Institut Godinot
Department Name
Service d'oncologie médicale
Principal Investigator Name
Aude-Marie SAVOYE
Principal Investigator Email
aude-marie.savoye@reims.unicancer.fr
Contact Person Name
Aude-Marie SAVOYE
Site Name
Institut Gustave Roussy
Department Name
Service d'oncologie médicale
Principal Investigator Name
Judith MICHEL
Principal Investigator Email
judith.michels@gustaveroussy.fr
Contact Person Name
Judith MICHEL
Site Name
Centre Hospitalier Regional D'orleans
Department Name
Service d'oncologie médicale
Principal Investigator Name
Elise CHAMPEAUX-ORANGE
Principal Investigator Email
elise.champeaux-orange@chr-orleans.fr
Contact Person Name
Elise CHAMPEAUX-ORANGE
Site Name
Polyclinique De Gentilly
Department Name
Service d'oncologie médicale
Principal Investigator Name
Fabien BROCARD
Principal Investigator Email
f.brocard@ilcgroupe.fr
Contact Person Name
Fabien BROCARD
Contact Person Email
f.brocard@ilcgroupe.fr
Site Name
Centre Jean Perrin
Department Name
Service d'oncologie médicale
Principal Investigator Name
Laure VACHER
Principal Investigator Email
laure.vacher@clermont.unicancer.fr
Contact Person Name
Laure VACHER
Site Name
Limoges University Hospital Dupuytren 1
Department Name
Service d'Oncologie Médicale
Principal Investigator Name
Laurence Venat Bouvet
Principal Investigator Email
laurence.venat-bouvet@chu-limoges.fr
Contact Person Name
Laurence Venat Bouvet
Site Name
Centre Francois Baclesse
Department Name
Service d'oncologie médicale
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
Hopital Prive Des Cotes D'armor
Department Name
Service d'oncologie médicale
Principal Investigator Name
Anne-Claire HARDY-BESSARD
Principal Investigator Email
ac.hardy@cario-sante.fr
Contact Person Name
Anne-Claire HARDY-BESSARD
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Service d'oncologie médicale
Principal Investigator Name
Laurianne EBERST
Principal Investigator Email
l.eberst@icans.eu
Contact Person Name
Laurianne EBERST
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d'oncologie médicale
Principal Investigator Name
Marie CHAIX
Principal Investigator Email
marie.chaix@chu-dijon.fr
Contact Person Name
Marie CHAIX
Contact Person Email
marie.chaix@chu-dijon.fr

Italy

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
695
Number Of Sites
7
Number Of Participants
75

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
gynecology oncology
Principal Investigator Name
Francesco Raspagliesi
Principal Investigator Email
raspagliesi.studi@istitutotumori.mi.it
Contact Person Name
Francesco Raspagliesi
Site Name
Careggi University Hospital
Department Name
Gynecological Medical Oncology
Principal Investigator Name
Maria Cristina Petrella
Principal Investigator Email
mariacristina.petrella@gmail.com
Contact Person Name
Maria Cristina Petrella
Site Name
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
Department Name
medical oncology
Principal Investigator Name
Alessandro Bertolini
Principal Investigator Email
alessandro.bertolini@asst-val.it
Contact Person Name
Alessandro Bertolini
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Department of Medical Area
Principal Investigator Name
Marcella Occelli
Principal Investigator Email
occelii.rn@ospedale.cuneo.it
Contact Person Name
Marcella Occelli
Contact Person Email
occelii.rn@ospedale.cuneo.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
ginecology oncology
Principal Investigator Name
Andrea Alberto Lissoni
Principal Investigator Email
andrealberto.lissoni@unimib.it
Contact Person Name
Andrea Alberto Lissoni
Contact Person Email
andrealberto.lissoni@unimib.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
gynecology oncology
Principal Investigator Name
Nicoletta Colombo
Principal Investigator Email
nicoletta.colombo@ieo.it
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
ginecology
Principal Investigator Name
Dionyssios Katsaros
Principal Investigator Email
d.katsaros@libero.it
Contact Person Name
Dionyssios Katsaros
Contact Person Email
d.katsaros@libero.it

Spain

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
672
Number Of Sites
16
Number Of Participants
30

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Medical Oncology
Principal Investigator Name
María José Bermejo
Principal Investigator Email
cheberpe@gmail.com
Contact Person Name
María José Bermejo
Contact Person Email
cheberpe@gmail.com
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Medical Oncology
Principal Investigator Name
Julen Fernández
Principal Investigator Email
julenfernandez@mutuaterrassa.cat
Contact Person Name
Julen Fernández
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Medical Oncology
Principal Investigator Name
Antonio González
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio González
Contact Person Email
agonzalezma@unav.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Medical Oncology
Principal Investigator Name
Alejandro Martínez
Principal Investigator Email
amartinez@oncorosell.com
Contact Person Name
Alejandro Martínez
Contact Person Email
amartinez@oncorosell.com
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Medical Oncology
Principal Investigator Name
Antonio González
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio González
Contact Person Email
agonzalezma@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Principal Investigator Name
Andrés Redondo
Principal Investigator Email
aredondo12@gmail.com
Contact Person Name
Andrés Redondo
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Medical Oncology
Principal Investigator Name
Nuria Lainez Milagro
Principal Investigator Email
nuria.lainez.milagro@cfnavarra.es
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital San Pedro De Alcantara
Department Name
Medical Oncology
Principal Investigator Name
Santiago González
Principal Investigator Email
santigsanti@gmail.com
Contact Person Name
Santiago González
Contact Person Email
santigsanti@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology
Principal Investigator Name
Juan Fernando Cueva
Principal Investigator Email
juan.fernando.cueva.banuelos@sergas.es
Contact Person Name
Juan Fernando Cueva
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical Oncology
Principal Investigator Name
María Quindós
Principal Investigator Email
maria.quindos.varela@sergas.es
Contact Person Name
María Quindós
Contact Person Email
maria.quindos.varela@sergas.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology
Principal Investigator Name
Constanza Maximiano
Principal Investigator Email
conxtanza@gmail.com
Contact Person Name
Constanza Maximiano
Contact Person Email
conxtanza@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Medical Oncology
Principal Investigator Name
Isabel Palacio
Principal Investigator Email
isabel.palacio@sespa.es
Contact Person Name
Isabel Palacio
Contact Person Email
isabel.palacio@sespa.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
José Alejandro Pérez
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
José Alejandro Pérez
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Medical Oncology
Principal Investigator Name
Ana Isabel Vacas
Principal Investigator Email
anavrama@gmail.com
Contact Person Name
Ana Isabel Vacas
Contact Person Email
anavrama@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Medical Oncology
Principal Investigator Name
Ana Puertes
Principal Investigator Email
jeronimo@seom.org
Contact Person Name
Ana Puertes
Contact Person Email
jeronimo@seom.org
Site Name
Hospital Del Mar
Department Name
Medical Oncology
Principal Investigator Name
Álvaro Taus
Principal Investigator Email
96720@parcdesalutmar.cat
Contact Person Name
Álvaro Taus
Contact Person Email
96720@parcdesalutmar.cat

Belgium

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
405
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
UZ Leuven
Department Name
Gynaecological Oncology
Principal Investigator Name
Els Van Nieuwenhuysen
Principal Investigator Email
els.vannieuwenhuysen@uzleuven.be
Contact Person Name
Els Van Nieuwenhuysen
Site Name
AZ Sint-Lucas & Volkskliniek
Department Name
Oncology
Principal Investigator Name
Stephanie De Waele
Principal Investigator Email
stefanie.dewaele@azstlucas.be
Contact Person Name
Stephanie De Waele
Contact Person Email
stefanie.dewaele@azstlucas.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Stephanie Henry
Principal Investigator Email
stephanie.henry@chuuclnamur.uclouvain.be
Contact Person Name
Stephanie Henry

Sponsor

Primary sponsor

Full Name
Arcagy Gineco
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
France

Contract research organisations

Name
Almac Clinical Services (Ireland) Limited
Responsibilities
14
Name
Almac Clinical Services Limited
Responsibilities
14

Third parties

  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MVASI 25 mg/mL concentrate for solution for infusion
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/17/1246/002)
Frequency
Every 3 weeks (when used as described); inclusion criteria: 15 mg/kg every 3 weeks
Maximum Dose
15 mg/kg (per inclusion/product maxDailyDoseAmount)
Investigational Product Name
Zejula 100 mg film-coated tablets
Active Substance
NIRAPARIB TOSILATE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/17/1235/004)
Frequency
Not specified in JSON (product maxDailyDoseAmount 300 mg)
Maximum Dose
300 mg (product maxDailyDoseAmount)
Investigational Product Name
Zejula 100 mg hard capsules
Active Substance
NIRAPARIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/17/1235/001)
Frequency
Not specified in JSON (product maxDailyDoseAmount 300 mg)
Maximum Dose
300 mg (product maxDailyDoseAmount)
Investigational Product Name
NIRAPARIB TOSILATE MONOHYDRATE (sponsor product GSK3985771)
Active Substance
NIRAPARIB TOSILATE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Sponsor product (prodAuthStatus=1) - not standard marketing authorisation listed
Frequency
Not specified in JSON (product maxDailyDoseAmount 300 mg)
Maximum Dose
300 mg (product maxDailyDoseAmount)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.