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A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation (RAMP 201)

Primary Purpose

Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
avutometinib (VS-6766)
avutometinib (VS-6766) and defactinib
Sponsored by
Verastem, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Grade Ovarian Serous Adenocarcinoma focused on measuring Low Grade Serous Ovarian Cancer, KRAS, KRAS wt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven LGSOC (ovarian, peritoneal)
  • In Part A KRAS mutation, KRAS wt
  • Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive

Exclusion Criteria:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • Co-existing high-grade ovarian cancer or another histology
  • History of prior malignancy with recurrence <3 years from the time of enrollment
  • Major surgery within 4 weeks
  • Symptomatic brain metastases requiring steroids or other interventions
  • Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
  • For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
  • Active skin disorder that has required systemic therapy within the past year
  • History of rhabdomyolysis
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications

Sites / Locations

  • Arizona Oncology Associates PC HALRecruiting
  • Sansum ClinicRecruiting
  • Yale School of MedicineRecruiting
  • Advent HealthRecruiting
  • H. Lee Moffitt Cancer Center and Research Institute - Center for Women's OncologyRecruiting
  • University of ChicagoRecruiting
  • Maryland Oncology and Hematology, P.A.Recruiting
  • Minnesota Oncology Hematology PARecruiting
  • Washington University School of MedicineRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • University of New Mexico Comprehensive Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Cleveland Clinic Women's Health InstituteRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • University of Oklahoma Medical CenterRecruiting
  • Willamette Valley Cancer Institute and Research CenterRecruiting
  • Northwest Cancer SpecialistsRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Texas Oncology Austin CentralRecruiting
  • Texas Oncology- Dallas Presbyterian HospitalRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Texas OncologyRecruiting
  • Texas OncologyRecruiting
  • Texas OncologyRecruiting
  • Texas OncologyRecruiting
  • University of Virginia Health SystemRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • UZ Gent Medische OncologieRecruiting
  • UZ LeuvenRecruiting
  • CHU de LiegeRecruiting
  • Centre de recherche di Centre Hospitalier de i'Universite de MontrealRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Hopital Jean Minjoz
  • Centre Leon BerardRecruiting
  • ICM - Val d'AurelleRecruiting
  • Institut CurieRecruiting
  • Insituto Europeo di Oncologia I.R.C.C.SRecruiting
  • U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.Recruiting
  • Hospital Universitario Vall D'HebronRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Western General HospitalRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • UCLH Cancer Clinical Trials UnitRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • Royal Marsden HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A

Part B

Part C:

Part D

Arm Description

To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)

To determine the efficacy of the optimal regimen identified from Part A

To evaluate additional efficacy parameters for the optimal regimen identified in Part A.

To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib

Outcomes

Primary Outcome Measures

Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
Confirmed overall response rate per RECIST 1.1
Part B: To determine the efficacy of the optimal regimen identified from Part A
Confirmed overall response rate per RECIST 1.1
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A
Confirmed overall response rate per RECIST 1.1
Part D:To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Confirmed ORR defined according to RECIST 1.1

Secondary Outcome Measures

Overall Response Rate as assessed by Investigator
Proportioned subjects achieving a CR or PR as assess by the investigator
Duration of Response (DOR)
From time of first response to PD as assessed by the BIRC
Disease Control Rate (DCR)
CR+PR+stable disease
Progression Free Survival (PFS)
From time of first dose of study intervention to PD or death for any cause
Overall Survival (OS)
From time of first dose of study intervention to death

Full Information

First Posted
November 5, 2020
Last Updated
September 13, 2023
Sponsor
Verastem, Inc.
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04625270
Brief Title
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
Acronym
RAMP 201
Official Title
A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verastem, Inc.
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Detailed Description
This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer
Keywords
Low Grade Serous Ovarian Cancer, KRAS, KRAS wt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Experimental
Arm Description
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
Arm Title
Part B
Arm Type
Experimental
Arm Description
To determine the efficacy of the optimal regimen identified from Part A
Arm Title
Part C:
Arm Type
Experimental
Arm Description
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
Arm Title
Part D
Arm Type
Experimental
Arm Description
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Intervention Type
Drug
Intervention Name(s)
avutometinib (VS-6766)
Intervention Description
avutometinib (VS-6766) monotherapy
Intervention Type
Drug
Intervention Name(s)
avutometinib (VS-6766) and defactinib
Other Intervention Name(s)
avutometinib (VS-6766) and VS-6063
Intervention Description
avutometinib (VS-6766) and defactinib combination
Primary Outcome Measure Information:
Title
Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
Part B: To determine the efficacy of the optimal regimen identified from Part A
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
Part D:To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Description
Confirmed ORR defined according to RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate as assessed by Investigator
Description
Proportioned subjects achieving a CR or PR as assess by the investigator
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
Duration of Response (DOR)
Description
From time of first response to PD as assessed by the BIRC
Time Frame
Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months
Title
Disease Control Rate (DCR)
Description
CR+PR+stable disease
Time Frame
Greater than or equal to 8 weeks
Title
Progression Free Survival (PFS)
Description
From time of first dose of study intervention to PD or death for any cause
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
From time of first dose of study intervention to death
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven LGSOC (ovarian, peritoneal) Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. Measurable disease according to RECIST 1.1 An Eastern Cooperative Group (ECOG) performance status ≤ 1. Adequate organ function Adequate recovery from toxicities related to prior treatments Agreement to use highly effective method of contraceptive, if necessary Exclusion Criteria: Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy Co-existing high-grade ovarian cancer or another histology History of prior malignancy with recurrence <3 years from the time of enrollment Major surgery within 4 weeks Symptomatic brain metastases requiring steroids or other interventions Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor Active skin disorder that has required systemic therapy within the past year History of rhabdomyolysis Concurrent ocular disorders Concurrent heart disease or severe obstructive pulmonary disease Subjects with the inability to swallow oral medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verastem Call Center
Phone
781-292-4204
Email
clinicaltrials@verastem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Banerjee, MBBS,MA,PhD
Organizational Affiliation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Grisham, MD
Organizational Affiliation
GOG Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MD Verastem
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates PC HAL
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amela Ahmetovic
Email
Amela.ahmetovic@usoncology.com
First Name & Middle Initial & Last Name & Degree
Mei Yu
Email
myu@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Bradley J Monk, MD
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Heitkamp
Phone
805-879-0643
Email
hheitkam@ridleytreecc.org
First Name & Middle Initial & Last Name & Degree
Gregg Newman, MD
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Baker
Email
lisa.baker@yale.edu
First Name & Middle Initial & Last Name & Degree
Alessandro Santin, MD
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Ricaute
Email
Alejandra.Ricaute@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Robert Holloway, MD
Facility Name
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaToya Hyde
Email
Latoya.Hyde@moffitt.org
First Name & Middle Initial & Last Name & Degree
Hye Sook Chon, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatti Koning
Email
hkoning@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
John Maroney, MD
Facility Name
Maryland Oncology and Hematology, P.A.
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corilynn Hughes
Email
Corilynn.Hughes@usoncology.com
First Name & Middle Initial & Last Name & Degree
Carol Tweed, MD
Facility Name
Minnesota Oncology Hematology PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nykole Starks
Email
Nykole.Starks@usoncology.com
First Name & Middle Initial & Last Name & Degree
Lauren Bollinger, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Russell
Email
swrussell@wustl.edu
First Name & Middle Initial & Last Name & Degree
Premal Thaker, MD
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Lovelace
Email
ann.lovelace@usoncology.com
First Name & Middle Initial & Last Name & Degree
Anu Thummala, MD
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Byatt
Email
lpbyatt@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Muller, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Grisham
Phone
646-888-4653
First Name & Middle Initial & Last Name & Degree
Rachel Grisham, MD
Facility Name
Cleveland Clinic Women's Health Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna White
Email
Whited11@ccf.org
First Name & Middle Initial & Last Name & Degree
Peter Rose, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Prizzi
Email
Erika.Prizzi@osumc.edu
First Name & Middle Initial & Last Name & Degree
David O'Malley, MD
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Dobbs
Email
Erika-Dobbs@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, MD
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Fisher
Email
Nichole.Fisher@usoncology.com
First Name & Middle Initial & Last Name & Degree
Jeanne Schaffer
Email
jeanne.schaffer@usoncology.com
First Name & Middle Initial & Last Name & Degree
Charles Anderson, MD
Facility Name
Northwest Cancer Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Kern
Email
Julian.Kern@usoncology.com
First Name & Middle Initial & Last Name & Degree
Erin Salinas, MD
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy Long
Email
Kristy.Long@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Erika Hamilton, MD
Facility Name
Texas Oncology Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Owens
Email
Michelle.Owens@usoncology.com
First Name & Middle Initial & Last Name & Degree
Lynne Knowles, MD
Facility Name
Texas Oncology- Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Heim
Email
morgan.heim@usoncology.com
First Name & Middle Initial & Last Name & Degree
Nancy Jones
Email
Nancy.Jones@usoncology.com
First Name & Middle Initial & Last Name & Degree
Kristi McIntyre, MD
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Thomas
Email
Tiffany.Thomas@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
David Miller, MD
Facility Name
Texas Oncology
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Maxfield
Email
Shelly.Maxfield@USOncology.com
First Name & Middle Initial & Last Name & Degree
Anna M Priebe, MD
Facility Name
Texas Oncology
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nereida Salinas
Email
nereida.salinas@usoncology.com
First Name & Middle Initial & Last Name & Degree
Suresh Ratnam, MD
Facility Name
Texas Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Bock
Email
Alice.Bock@usoncology.com
First Name & Middle Initial & Last Name & Degree
Debora Lind
Email
Debora.Lind@usoncology.com
First Name & Middle Initial & Last Name & Degree
Antonio Santillian-Gomez, MD
Facility Name
Texas Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Genthon
Email
Christina.Genthon@usoncology.com
First Name & Middle Initial & Last Name & Degree
Sandra Thornton
Email
Sandra..Thornton@usoncology.com
First Name & Middle Initial & Last Name & Degree
Christine Lee, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Lacy
Email
RMC9P@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Chrystal Axford
Email
CGP9E@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Kari Ring, MD
Facility Name
Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Cochrane
Email
Monica.Cochrane@usoncology.com
First Name & Middle Initial & Last Name & Degree
Marcy Sullivan
Email
Marcy.Sullivan@usoncology.com
First Name & Middle Initial & Last Name & Degree
Mitul Gandhi, MD
First Name & Middle Initial & Last Name & Degree
Alex Spira, MD
Facility Name
UZ Gent Medische Oncologie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Els Stommeleier
Email
els.stommelier@uzgent.be
First Name & Middle Initial & Last Name & Degree
Hannelore Denys, MD
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toon Van Gorp
Email
toon.vangorp@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Toon Van Gorp, MD
Facility Name
CHU de Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Denis
Email
chloe.denis@chuliege.be
First Name & Middle Initial & Last Name & Degree
Christine Gennigens, MD
Facility Name
Centre de recherche di Centre Hospitalier de i'Universite de Montreal
City
Montréal
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Provencher
Email
diane.provencher.med@sss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Diane Provencher, MD
Facility Name
Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Oza
Email
Amit.Oza@uhn.ca
First Name & Middle Initial & Last Name & Degree
Amit Oza, MD
Facility Name
Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
2500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clovis Boibessot
Email
cboibessot@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Elsa Kalbacher, MD
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibtissame Djedoui
Email
Ibtissame.DJEDOUI@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Ray-Coquard, MD
Facility Name
ICM - Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Fabbro
Phone
33 (0)4 67 61 30 63
Email
michel.fabbro@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Michel Fabbro, MD
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Faye
Email
audrey.faye@curie.fr
First Name & Middle Initial & Last Name & Degree
Manuel Rodrigues, MD
Facility Name
Insituto Europeo di Oncologia I.R.C.C.S
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoletta Colombo
Email
Nicoletta.colombo@ieo.it
First Name & Middle Initial & Last Name & Degree
Nicoletta Colombo, MD
Facility Name
U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Guarneri
Email
valentina.guarneri@unipd.it
First Name & Middle Initial & Last Name & Degree
Valentina Guarneri, MD
Facility Name
Hospital Universitario Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alba Meire
Email
ameire@vhio.net
First Name & Middle Initial & Last Name & Degree
Ana Oaknin, MD
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Rubio
Email
mjesusrubio@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Jesus Rubio, MD
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Cortes-Salgado
Email
acsalgado86@gmail.com
First Name & Middle Initial & Last Name & Degree
Alfonso Cortes -Salgado, MD
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Alejandro Perez Fidalgo
First Name & Middle Initial & Last Name & Degree
Jose Alejandro Perez Fidalgo, MD
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Simpson
Phone
0131 537 1234
Email
Ryan.Simpson@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Charlie Gourley, MD
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G120YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Fairley
Email
shannon.fairley@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Rosalind Glasspool, MD
Facility Name
UCLH Cancer Clinical Trials Unit
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Hawkes-Blackburn
Phone
07790 895740
Email
m.hawkes-blackburn@nhs.net
First Name & Middle Initial & Last Name & Degree
Rowan Miller, MD
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Clamp
Email
andrew.clamp@nhs.net
First Name & Middle Initial & Last Name & Degree
Andrew Clamp, MD
Facility Name
Royal Marsden Hospital
City
Sutton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylie Fitch
First Name & Middle Initial & Last Name & Degree
Kylie.Fitch@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Susana Banerjee, MD

12. IPD Sharing Statement

Learn more about this trial

A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

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