CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 270 target
Drug / intervention
avutometinib +5 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed low-grade serous ovarian cancer (ovarian, fallopian tube, or peritoneal origin)
  • ✓Documented KRAS mutation status by validated tumor tissue test
  • ✓Progression or recurrence after at least one prior systemic therapy for metastatic disease
  • ✓Measurable disease by RECIST v1.1
Key exclusion· 15
  • ✕High-grade serous ovarian cancer or mixed histology
  • ✕Prior treatment with avutometinib, defactinib, or other FAK inhibitors
  • ✕Prior malignancy with recurrence <3 years from enrollment
  • ✕Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06072781
NCT06072781Phase 3RecruitingOn TrackUpdated 2mo ago
CompareCT.gov

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)

Verastem, Inc.·interventional·Posted Oct 10, 2023·Updated Apr 2, 2026

In Brief

A Phase 3 clinical trial evaluating avutometinib, Defactinib, and 4 other interventions for Low Grade Serous Ovarian Cancer. Currently recruiting, targeting 270 participants across 106 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Grade Serous Ovarian Cancer
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, South Korea, Spain, United Kingdom, United States
CollaboratorsGOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Australia New Zealand Gynaecological Oncology Group, Korean Gynecologic Oncology Group

Timeline

Phase 3Recruiting
20242025202620272028202920302031
First PostedOct 10, 2023
Enrollment StartMar 18, 2024
Primary CompletionOct 15, 2028
Study CompletionFeb 9, 2031
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 2.7 years agoPrimary completion in 2.3 years

Interventions

avutometinibdrug

Avutometinib: administered orally

Defactinibdrug

Defactinib: administered orally

Pegylated liposomal doxorubicindrug

administered intravenously

Paclitaxeldrug

administered intravenously

Letrozoledrug

administered orally

Anastrozoledrug

administered orally