Clinical Trials in Italy / NCT04625270
Active, not recruiting
Phase 2
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
NCT04625270 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Low Grade Ovarian Serous AdenocarcinomaOvarian Cancer
Investigational drug(s) / intervention(s)
avutometinib (VS-6766): avutometinib (VS-6766) monotherapy
avutometinib (VS-6766) and defactinib: avutometinib (VS-6766) and defactinib combination
Study 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)
Eligibility
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
Primary outcome measure(s)
- Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib — From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1 - Part B: To determine the efficacy of the optimal regimen identified from Part A — From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1 - Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A — From start of treatment to confirmation of response; 24 weeks
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 — From start of treatment to confirmation of response; 24 weeks
Confirmed ORR defined according to RECIST 1.1
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology Associates PC HAL | Scottsdale | Arizona | |
| Sansum Clinic | Santa Barbara | California | |
| Yale School of Medicine | New Haven | Connecticut | |
| Advent Health | Orlando | Florida | |
| H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology | Tampa | Florida | |
| University of Chicago | Chicago | Illinois | |
| Maryland Oncology and Hematology, P.A. | Glenn Dale | Maryland | |
| Minnesota Oncology Hematology PA | Minneapolis | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Cleveland Clinic Women's Health Institute | Cleveland | Ohio | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | |
| Northwest Cancer Specialists | Portland | Oregon | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| Texas Oncology Austin Central | Austin | Texas | |
| Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas | |
| UT Southwestern Medical Center | Dallas | Texas | |
| Texas Oncology | Longview | Texas | |
| Texas Oncology | McAllen | Texas | |
| Texas Oncology | San Antonio | Texas | |
| Texas Oncology | The Woodlands | Texas | |
| University of Virginia Health System | Charlottesville | Virginia | |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | |
| UZ Gent Medische Oncologie | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| CHU de Liege | Liège | Belgium | |
| Centre de recherche di Centre Hospitalier de i'Universite de Montreal | Montreal | Canada | |
| Princess Margaret Cancer Centre | Toronto | Canada | |
| Hopital Jean Minjoz | Besançon | France | |
| Centre Leon Berard | Lyon | France | |
| ICM - Val d'Aurelle | Montpellier | France | |
| Institut Curie | Paris | France | |
| Insituto Europeo di Oncologia I.R.C.C.S | Milan | Italy | |
| U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S. | Padova | Italy | |
| Hospital Universitario Vall D'Hebron | Barcelona | Spain | |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
+ 7 more sites — see the full list on the official registry below.
More Verastem, Inc. trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04625270 on ClinicalTrials.gov ↗ ← All trials in Italy