Clinical trial • Phase III • Oncology

Avutometinib for Low-grade serous ovarian cancer | Recurrent low-grade serous ovarian cancer

Phase III trial of Avutometinib for Low-grade serous ovarian cancer | Recurrent low-grade serous ovarian cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Low-grade serous ovarian cancer | Recurrent low-grade serous ovarian cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
31-01-2024
First CTIS Authorization Date
22-05-2024

Trial design

Randomised, open-label, investigator’s choice of treatment (ict): pegylated liposomal doxorubicin (e.g., zolsketil / caelyx; iv infusion; listed max dose 40 mg/m2), paclitaxel (e.g., paclitaxel aqvida / ribosepharm; iv infusion; listed max dose 80 mg/m2), topotecan (topotecan hexal; iv infusion; listed max dose 4 mg/m2), letrozole (oral; listed dose up to 2.5 mg daily), anastrozole (oral; listed dose 1 mg daily). (comparator choice determined by investigator based on patient history, prior treatments, availability and country approval.)-controlled Phase III trial in Belgium, Spain, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s Choice of Treatment (ICT): pegylated liposomal doxorubicin (e.g., ZOLSKETIL / Caelyx; IV infusion; listed max dose 40 mg/m2), paclitaxel (e.g., Paclitaxel AqVida / Ribosepharm; IV infusion; listed max dose 80 mg/m2), topotecan (Topotecan HEXAL; IV infusion; listed max dose 4 mg/m2), letrozole (oral; listed dose up to 2.5 mg daily), anastrozole (oral; listed dose 1 mg daily). (Comparator choice determined by Investigator based on patient history, prior treatments, availability and country approval.)
Biomarker Stratified
True; biomarker: KRAS mutational status (strata not specified)
Target Sample Size
125

Eligibility

Recruits 125 No vulnerable population selected. Participants are adults (Age ≥ 18 years). Informed consent obtained from adult participants; assent not applicable..

Pregnancy Exclusion
For patients with reproductive potential, a negative serum pregnancy test (β human chorionic gonadoptropnin [β-hCG]) no more than 7 days prior to randomization, verified by the treating physician.
Vulnerable Population
No vulnerable population selected. Participants are adults (Age ≥ 18 years). Informed consent obtained from adult participants; assent not applicable.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years\n- Histologically proven LGSOC (ovarian, fallopian, peritoneal) a. No mixed histology; LGSOC in conjunction with serous borderline tumor is permitted b. Adequate tumor tissue (as defined in the lab manual) must be available for central confirmation of LGSOC. Adequate tumor tissue (as defined in the lab manual) must be received by the central laboratory prior to randomization. If the patient does not have adequate archived tumor tissue or the archived tumor was obtained more than 5 years from informed consent, then a fresh tumor sample will be needed to support eligibility. Central pathological confirmation does not need to be completed prior to randomization.\n- Suitable for treatment with at least one of the Investigator’s Choice of Treatments (ie, pegylated liposomal doxorubicin, paclitaxel, topotecan, letrozole, anastrozole) as determined by the Investigator, given the medical history, prior treatment(s), availability, and approval within a given country, and other relevant factors.\n- Documented progression (radiographic or clinical) or recurrence of LGSOC after at least one platinum-based chemotherapy regimen. Allowed prior treatments and therapies include: a. Prior systemic therapy for metastatic disease (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) may consist of chemotherapy administered with or without bevacizumab, with or without maintenance therapy; or hormonal therapy. b. One prior line of treatment with a MEK and/or RAF inhibitor is permitted only if there was prior clinical benefit (objective response or stable disease ≥ 6 months) and not received within 6 months of signing informed consent.\n- Adequate organ function, defined by the following laboratory parameters: a. Adequate hematologic function, including hemoglobin [Hb] ≥ 9.0 g/dL; platelets ≥ 100,000/mm3; and absolute neutrophil count [ANC] ≥ 1500/mm3. If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the Hb must remain stable and ≥ 9 g/dL for at least 1 week prior to first dose of study intervention. b. Adequate hepatic function: (i) total bilirubin ≤ 1.5 × upper limit of normal [ULN] for the institution; patients with Gilbert syndrome may enroll if total bilirubin is < 3.0 mg/dL (51 μmol/L); (ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or < 5 x ULN in patients with liver metastases). c. Adequate renal function with creatinine clearance rate of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula or serum creatinine of ≤ 1.5 x ULN. d. International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation. e. Albumin ≥ 3.0 g/dL (451 μmol/L). f. Creatine phosphokinase (CPK) ≤ 2.5 x ULN. g. Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n- Baseline QTc interval ≤ 460 ms using Fredericia’s QT correction formula. NOTE: This criterion does not apply to patients with a right or left bundle branch block.\n- Documented mutational status of KRAS by an approved diagnostic test (eg, CDx, CE marked etc) from tumor tissue (Section 8.4.10). Adequate tumor tissue and matched normal (as defined in the lab manual) must be received by the central laboratory prior to randomization. If the patient does not have adequate archived tumor tissue or the archived tumor was obtained more than 5 years from informed consent, then a fresh tumor sample will be needed to support eligibility. Central confirmation of mutational status does not need to be completed prior to randomization.\n- At least one measurable lesion according to RECIST v1.1.\n- Eastern Cooperative Group (ECOG) performance status ≤ 1.\n- Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n- For patients with reproductive potential, a negative serum pregnancy test (β human chorionic gonadoptropnin [β-hCG]) no more than 7 days prior to randomization, verified by the treating physician.\n- For patients with reproductive potential, agreement to use highly effective method of contraceptive (per Clinical Trial Facilitation Group [CFTG] recommendations) during the trial and for 30 days following the last dose of study intervention"}

Exclusion criteria

  • {"criterion_text":"- Received a systemic (targets the entire body) cancer treatment within 4 weeks of the first dose of study therapy;\n- Have had a serious reaction to a MEK (mitogen-activated protein kinase kinase) inhibitor in the past;\n- Have had symptomatic bowel blockage within 3 months prior to treatment;\n- Currently have eye disorders;\n- Currently have heart disease or severe obstructive pulmonary disease;\n- Are not able to swallow medicines given by mouth; or Have active, uncontrolled infections (bacterial, viral, or fungal) requiring systemic therapy.\n- Currently have high-grade ovarian cancer or another ovarian cancer subtype;\n- Have had prior treatment with avutometinib, defactinib, or other FAK kinase inhibitors similar to defactinib;\n- Have a history of prior cancer that came back less than 3 years from the time of enrollment;\n- Had a major surgery within 4 weeks prior to treatment;\n- Have symptomatic brain cancer or a spinal cord involvement;\n- Have an active skin disorder that has required a systemic treatment within 1 year of signing informed consent;\n- Have a history of medically significant rhabdomyolysis (rare muscle injury where the muscles break down);"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, per blinded independent central review (BICR)","definition_or_measurement_approach":"PFS per RECIST v1.1 assessed by blinded independent central review (BICR). Tumor growth measured using CT or MRI scans; imaging reviewed by an independent review committee."}

Secondary endpoints

  • {"endpoint_text":"- Unless otherwise specified, all tumor response-based endpoints will be analyzed using both BICR and Investigator assessments.\n- Overall Survival (OS)\n- PFS according to RECIST v1.1, per Investigator Assessment\n- Objective response rate (ORR)\n- Duration of response (DoR)\n- Disease control rate (DCR), defined as having achieved a best response of complete response (CR) or partial response (PR), or stable disease (SD) documented at ≥ Week 24","definition_or_measurement_approach":"Tumor response endpoints analysed by both BICR and Investigator assessments; imaging by CT/MRI. OS measured as time from randomization to death. PFS per RECIST v1.1 by Investigator assessment. DCR defined as CR or PR or SD documented at ≥ Week 24."}

Recruitment

Planned Sample Size
125
Recruitment Window Months
77
Consent Approach
Informed consent obtained from adult participants (Age ≥ 18). Subject information sheets and informed consent forms available in multiple language versions (examples in document list: ENG, FRA, FRA(BE), ESP, DEU, ITA, NL, DK, PL). Pre-screening and main adult ICF/SIS documents provided; assent not applicable.

Geography

Total Number Of Sites
47
Total Number Of Participants
183

Belgium

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
592
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Konstantinos Papadimitriou
Principal Investigator Email
oncotrials@uza.be
Contact Person Name
Konstantinos Papadimitriou
Contact Person Email
oncotrials@uza.be
Site Name
UZ Leuven
Department Name
Oncology
Principal Investigator Name
Els Van Nieuwenhuysen
Principal Investigator Email
els.vannieuwenhuysen@uzleuven.be
Contact Person Name
Els Van Nieuwenhuysen
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
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Principal Investigator Name
Denys Hannelore
Principal Investigator Email
hannelore.denys@ugent.be
Contact Person Name
Denys Hannelore
Contact Person Email
hannelore.denys@ugent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology
Principal Investigator Name
Christine Gennigens
Principal Investigator Email
christine.gennigens@chuliege.be
Contact Person Name
Christine Gennigens

Spain

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
576
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
José Alejandro Pérez Fidalgo
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
José Alejandro Pérez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Ana Oaknin Benzaquen
Principal Investigator Email
aoaknin@vhio.net
Contact Person Name
Ana Oaknin Benzaquen
Contact Person Email
aoaknin@vhio.net
Site Name
Hospital Universitario Donostia
Department Name
Medical Oncology
Principal Investigator Name
Cristina Churruca
Principal Investigator Email
cristinamaria.churrucagala@osakidetza.eus
Contact Person Name
Cristina Churruca
Site Name
Hospital General Universitario Reina Sofia
Department Name
Medical Oncology
Principal Investigator Name
María Jésus Rubio Pérez
Principal Investigator Email
mjsusrubio63@gmail.com
Contact Person Name
María Jésus Rubio Pérez
Contact Person Email
mjsusrubio63@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Medical Oncology
Principal Investigator Name
Ana Puertes
Principal Investigator Email
a.junio1986@gmail.com
Contact Person Name
Ana Puertes
Contact Person Email
a.junio1986@gmail.com
Site Name
Universidade De Santiago De Compostela
Principal Investigator Name
Juan Fernando Cueva
Principal Investigator Email
juan.fernando.cueva.banuelos@sergas.es
Contact Person Name
Juan Fernando Cueva
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Alfonso Cortés Salgado
Principal Investigator Email
acsalgado86@gmail.com
Contact Person Name
Alfonso Cortés Salgado
Contact Person Email
acsalgado86@gmail.com
Site Name
Hospital Universitario Donostia (additional listing)
Department Name
Medical Oncology
Principal Investigator Name
Cristina Churruca
Principal Investigator Email
cristinamaria.churrucagala@osakidetza.eus
Contact Person Name
Cristina Churruca
Site Name
Hospital Universitario Ramon Y Cajal (additional listing)
Department Name
Medical Oncology
Principal Investigator Name
Alfonso Cortés Salgado
Principal Investigator Email
acsalgado86@gmail.com
Contact Person Name
Alfonso Cortés Salgado
Contact Person Email
acsalgado86@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
227
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Aalborg University Hospital
Department Name
Oncology
Principal Investigator Name
Charlotte Aaquist Haslund
Principal Investigator Email
cah@rn.dk
Contact Person Name
Charlotte Aaquist Haslund
Contact Person Email
cah@rn.dk

Italy

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
607
Number Of Sites
13
Number Of Participants
60

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Unità di Ginecologia Oncologica
Principal Investigator Name
Domenica Lorusso
Principal Investigator Email
domenica.lorusso@sanpiox.humanitas.it
Contact Person Name
Domenica Lorusso
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica, SOC di Oncologia Medica e Prevenzione Oncologica
Principal Investigator Name
Michele Bartoletti
Principal Investigator Email
michele.bartoletti@cro.it
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Germana Tognon
Principal Investigator Email
germanatognon@gmail.com
Contact Person Name
Germana Tognon
Contact Person Email
germanatognon@gmail.com
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Oncology
Principal Investigator Name
Giorgio Valabrega
Principal Investigator Email
giorgio.valabrega@unito.it
Contact Person Name
Giorgio Valabrega
Contact Person Email
giorgio.valabrega@unito.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Ginecologia Oncologica
Principal Investigator Name
Vanda Salutari
Principal Investigator Email
vanda.salutari@policlinicogemelli.it
Contact Person Name
Vanda Salutari
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology 1 Division
Principal Investigator Name
Antonella Savarese
Principal Investigator Email
antonella.savarese@ifo.it
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Giorgia Mangili
Principal Investigator Email
mangili.giorgia@hsr.it
Contact Person Name
Giorgia Mangili
Contact Person Email
mangili.giorgia@hsr.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Ginecologia Oncologia Medica
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Gynaecological Oncology
Principal Investigator Name
Mara Mantiero
Principal Investigator Email
mara.mantiero@istitutotumori.mi.it
Contact Person Name
Mara Mantiero
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia clinica e sperimentale di terapie innovative ed alte dosi
Principal Investigator Name
Ugo De Giorgi
Principal Investigator Email
Ugo.degiorgi@irst.emr.it
Contact Person Name
Ugo De Giorgi
Contact Person Email
Ugo.degiorgi@irst.emr.it
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Giuseppa Scandurra
Principal Investigator Email
giuseppa.scandurra@aoec.it
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giuseppa.scandurra@aoec.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
Principal Investigator Name
Sabrina Cecere
Principal Investigator Email
s.cecere@istitutotumori.na.it
Contact Person Name
Sabrina Cecere
Contact Person Email
s.cecere@istitutotumori.na.it

Germany

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
614
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie
Principal Investigator Name
Radoslav Chekerov
Principal Investigator Email
radoslav.chekerov@charite.de
Contact Person Name
Radoslav Chekerov
Contact Person Email
radoslav.chekerov@charite.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Principal Investigator Name
Barbara Schmalfeldt
Principal Investigator Email
b.schmalfeldt@uke.de
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Universitäts-Frauenklinik
Principal Investigator Name
Frederik Marmé
Principal Investigator Email
Frederik.Marme@umm.de
Contact Person Name
Frederik Marmé
Contact Person Email
Frederik.Marme@umm.de
Site Name
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Department Name
Gynecology & Oncology
Principal Investigator Name
Philipp Harter
Principal Investigator Email
P.Harter@kem-med.com
Contact Person Name
Philipp Harter
Contact Person Email
P.Harter@kem-med.com
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Principal Investigator Name
Marc Thill
Principal Investigator Email
marc.thill@agaplesion.de
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Gynäkologisches Krebszentrum
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
Pauline.Wimberger@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
Pauline.Wimberger@ukdd.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Fabienne Schochter
Principal Investigator Email
Fabienne.Schochter@uniklinik-ulm.de
Contact Person Name
Fabienne Schochter

Poland

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
245
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Principal Investigator Name
Lubomir Bodnar
Principal Investigator Email
lbodnar@szpital.siedlce.pl
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Principal Investigator Name
Dagmara Klasa-Mazurkiewicz
Principal Investigator Email
dklasa@gumed.edu.pl
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej
Principal Investigator Name
Beata Maćkowiak-Matejczyk
Principal Investigator Email
bmackowiak@onkologia.bialystok.pl
Contact Person Name
Beata Maćkowiak-Matejczyk

Netherlands

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
253
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Principal Investigator Name
Nelleke Ottevanger
Principal Investigator Email
nelleke.ottevanger@radboudumc.nl
Contact Person Name
Nelleke Ottevanger
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
M
Principal Investigator Name
Frans Opdam
Principal Investigator Email
f.opdam@nki.nl
Contact Person Name
Frans Opdam
Contact Person Email
f.opdam@nki.nl

Ireland

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
277
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Karen Cadoo
Principal Investigator Email
KCadoo@stjames.ie
Contact Person Name
Karen Cadoo
Contact Person Email
KCadoo@stjames.ie

France

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
06-01-2026
Processing Time Days
660
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Besancon University Hospital Center
Department Name
Medical Oncology
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
Centre Oscar Lambret
Department Name
Medical Oncology
Principal Investigator Name
Cyril ABDEDDAIM
Principal Investigator Email
c-abdeddaim@o-lambret.fr
Contact Person Name
Cyril ABDEDDAIM
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Centre Georges Francois Leclerc
Department Name
Medical Oncology
Principal Investigator Name
Jean-David Fumet
Principal Investigator Email
jdfumet@cgfl.fr
Contact Person Name
Jean-David Fumet
Contact Person Email
jdfumet@cgfl.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Véronique D'HONDT
Principal Investigator Email
Veronique.dhondt@icm.unicancer.fr
Contact Person Name
Véronique D'HONDT
Site Name
Institut Curie
Department Name
Medical Oncology
Principal Investigator Name
Manuel Rodrigues
Principal Investigator Email
manuel.rodrigues@curie.fr
Contact Person Name
Manuel Rodrigues
Contact Person Email
manuel.rodrigues@curie.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Isabelle Ray-Coquard
Principal Investigator Email
isabelle.ray-coquard@lyon.unicancer.fr
Contact Person Name
Isabelle Ray-Coquard

Sponsor

Primary sponsor

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

Contract research organisations

Name
Catalyst Clinical Research LLC
Responsibilities
sponsorDuties codes: 1,12,5; contact email: maxine.blake-ainslie@catalystcr.com

Third parties

  • {"country":"United States","full_name":"Catalyst Clinical Research LLC","duties_or_roles":"sponsorDuties codes: 1,12,5; contact email: maxine.blake-ainslie@catalystcr.com","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
VS-6766
Active Substance
Avutometinib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Investigational (no marketing authorisation indicated in product record)
Starting Dose
2 mg
Maximum Dose
2 mg
Investigational Product Name
VS-6063
Active Substance
Defactinib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Investigational (no marketing authorisation indicated in product record)
Maximum Dose
200 mg
Combination Treatment
Yes

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