Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UC Davis UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Ritu Salani, MD (ucla)
Headshot of Ritu Salani
Ritu Salani

Description

Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Official Title

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Details

This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both types of drugs called kinase inhibitors. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of four standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standards of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)

Keywords

Low Grade Serous Ovarian Cancer, KRAS, KRAS wt, KRAS mt, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Paclitaxel, Doxorubicin, Liposomal doxorubicin, Letrozole, Anastrozole, avutometinib, Defactinib, Pegylated liposomal doxorubicin, avutometinib + defactinib

Eligibility

Locations

  • UCLA Health accepting new patients
    Los Angeles California 90095 United States
  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Ritu Salani, MD (ucla)
    Professor, Obstetrics and Gynecology, Medicine. Authored (or co-authored) 157 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT06072781
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 270 study participants
Last Updated