Study Newsletter Third Quarter 2022
VS-6766 +/- defactinib
Protocol VS-6766-201/ENGOT Ov60/GOG 3052
Message from ENGOT-ov60/GOG 3052/RAMP 201 Study Team
Dear Investigators and Study Staff,

Thank you for your efforts recruiting women with low grade serous ovarian cancer to the ENGOTov60/GOG3052/RAMP201 study. All sites globally are now open for enrollment to the KRAS mutant arm. As of today, there are approximately 26 accrual slots remaining. Please continue to screen patients for this study, but be on the lookout for updates on accrual status.

RAMP 201 (ENGOT ov-60/ GOG 3052) Trial Updates
Enrollment to the KRAS mutant arm of the study remains open. Please continue your efforts to enroll patients on the KRAS mutant arm. Should you have questions on patient eligibility or other clinical questions, please do email the study team at ramp201@verastem.com.
Current Study Enrollment:

  • 123 Dosed (46 KRAS mt, 77 KRAS wt)
  • 81 in US ,13 in Belgium, 7 in UK, 6 in France, 8 in Spain, 8 in Italy

Data Entry and Outstanding Queries

  • Data Entry must be completed within 5 business days from visit date.
  • Kindly review data entry to ensure there are no extra spaces.
  • Queries must be responded to within 3 – 5 business days.
  • Verastem can provide you with a single list of outstanding queries as needed. Just click the button below to send an email request and we will will do the rest.
Frequently Asked Questions






Q: What days of the week can I initiate dosing?
A: Mon/Thu; Tue/Fri; Wed/Sat

Q: Patient just came in for C2D1. The dosing was interrupted due to a Grade 3 rash. The patient is scheduled to come in the following week. Assuming the rash has improved to < Grade 3, what cycle would this be considered?
A: The protocol states: “cycle must always remain 28 days even if there are dose modifications.” Thus this would be considered C2D8.

Q: Does the C3D1 “Blood for analysis of KRAS mutational status and other tumor genes” sample need to be collected if KRAS status is already known?
A: Yes, this sample should be collected at Screening, C3D1, and EOT as specified in the Schedule of Assessments. These samples are in addition to the sample used to confirm KRAS status locally and the sample sent to the central lab for central KRAS confirmation.
Available Patient Accrual Resources
Press Kit and Media Support
·   Template press release with local spokesperson
·   Trial fact sheet with inclusion/exclusion criteria
·   LGSOC fact sheet
·   Reporter outreach and interview coordination
RAMP 201 Web site www.RAMP201study.com (for patients)
·   Pre-screener questionnaire
·   Site locations
Social Media
·    RAMP 201 Facebook page
·    Template social posts
Template for RAMP 201 Ad
Template for Catchment Referral Letter
RAMP 201 (ENGOT ov-60/ GOG 3052) Sites
ENGOT
BGOG
  • Hannalore Denys, CHU Sart Tilman
  • Christine Gennigens, CHU de Liege 
  • Els van Nieuwenhuysen, UZ Leuven
Canada
  • Amit Oza, Princess Margaret Cancer Centre
  • Diane Provencher, Centre hospitalier de l'Université de Montréal
GEICO
  • Ana Oaknin, Vall d'Hebron Institute of Oncology
  • Alejandro Perez-Fidalgo, Hospital Clinico Universitario. Valencia
  • Eva Guerra, Universitario Ramón y Cajal
GINECO
  • Michel Fabbro, Institut du Cancer de Montpellier
  • Elsa Kalbacher, Centre Leon Berard
  • Isabelle Ray-Coquard, CHU de Besançon
  • Manuel Rodrigues, Institut Curie
MaNGO
  • Valentina Guarneri, Istituto Oncologico Veneto
  • Nicoletta Colombo, Istituto Europeo Oncologia
  • Maria Rubio, Universitario Reina Sofía
NCRI
  • Susana Banerjee, The Royal Marsden
  • Charlie Gourley, University of Edinburgh
  • Rosalind Glasspool, Beatson West of Scotland
  • Andrew Clamp, The Christie NHS Foundation
  • Rowan Miller, University College London
GOG
  • Charles Anderson, USO-Eugene, Oregon
  • Christine Lee, USO-The Woodlands, TX
  • Bradley Monk, USO-Phoenix, AZ
  • Emily Prendergast, USO-Minneapolis, MN
  • Anna Priebe USO-Tyler, TX
  • Michael Teneriello, USO-Austin, TX
  • Mitul Gandhi, USO-Gainesville, VA
  • Antonio Santillan, USO-San Antonio, TX
  • Gregg Newman, USO-Santa Barbara, CA
  • Suresh Ratnam, USO-McAllen, TX
  • Kari Ring, University of Virginia
  • Robert Holloway, Advent Health
  • Rachel Grisham, Memorial Sloan Kettering Cancer Center
  • Hye Sook Chon, Moffitt Cancer Center
  • Alessandro Santin, Yale
  • Premal Thaker, Washington University
  • John Moroney, University of Chicago
  • Carolyn Muller, University of New Mexico
  • Peter Rose, Cleveland Clinic
  • Kristin Bixel, The Ohio State
  • David Miller, University Texas Southwestern
  • Erika Hamilton, Tennessee Oncology
  • Kathleen Moore, University of Oklahoma
  • Anu Thummala, Comprehensive Cancer Centers of Neveda
  • Erin Salinas, Compass Oncology, Portland, OR
  • Carol Tweed, Maryland Oncology Hematology, Annapolis, MD
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Needham, MA 02494
781-292-4200
This newsletter and all information contained within are confidential and intended for RAMP 201 investigators and study staff only. Not for distribution.