The purpose of the RAMP 201 study, also referred to as a trial, is to see whether an investigational drug called VS-6766 given to patients with recurrent LGSOC with and without a KRAS mutation works better alone or when given in combination with a second investigational drug, defactinib. The trial will measure effectiveness, including overall response rate, as well as safety. The study is being conducted by gynecological cancer specialists.
If you are eligible and agree to participate in this study, you will be treated with either VS-6766 alone or a combination of VS-6766 with defactinib, for up to one year with follow up appointments. This is an open-label trial. Every patient will be treated with an active oral study drug, and their investigator will not be comparing it to a placebo.
VS-6766 and defactinib are investigational compounds that have not been approved by the U.S. Food and Drug Administration (FDA). Defactinib was granted Orphan Drug Designation in ovarian cancer and mesothelioma in the U.S., EU and Australia.
RAMP 201: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
VS-6766-201 (Verastem, Inc.)
Clinical Trial NCT04625270
ENGOT-ov60/NCRI (European Network for Gynaecological Oncological Trial groups)
GOG-3052 (The GOG Foundation)
Study Drugs or Compounds: VS-6766 and Defactinib (VS-6063)
Study Phase: Phase 2
Total Enrollment: Estimated at 100 patients
Study Short Title:
A Phase 2 Study of VS-6766 Alone and In Combination with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)