Actively Recruiting
A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
20
Participants Needed
8
Research Sites
152 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether the combination of avutometinib, defactinib, and letrozole is an effective treatment for people with low-grade serous ovarian cancer (LGSOC). The researchers will also look at the safety of this combination.
CONDITIONS
Official Title
A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years of age or older
- Histologically confirmed low-grade serous ovarian or peritoneal cancer by tissue biopsy
- Not suitable for primary surgery or have residual measurable disease after attempted surgery
- Measurable disease by RECIST 1.1 with lesions at least 10 mm or lymph nodes at least 15 mm
- ECOG performance status 0 or 1; status 2 allowed if due to cancer only
- Patients with treated or asymptomatic brain metastases under control
- HIV patients with undetectable viral load on effective therapy
- Patients with controlled hepatitis B or cured hepatitis C infection
- Prior or concurrent cancers that do not interfere with safety or treatment assessment
- Agree to use effective contraception during the trial and for 1 month after treatment if of reproductive potential
- Adequate heart function with ejection fraction 50% or higher
- Baseline QTc interval less than 460 ms unless bundle branch block present
- Adequate blood counts: hemoglobin at least 9.0 g/dL, platelets at least 100,000/mm3, neutrophils at least 1000/mm3
- Adequate liver function with bilirubin no more than 1.5 times upper limit or up to 3.0 mg/dL in Gilbert syndrome
- ALT and AST levels no more than 2.5 times upper limit or 5 times if liver metastases present
- Adequate kidney function with creatinine clearance 50 mL/min or higher or creatinine no more than 1.5 times upper limit
- Creatine phosphokinase no more than 2.5 times upper limit
You will not qualify if you...
- Candidates for primary debulking surgery unless residual disease remains after surgery
- Prior systemic anti-cancer therapy for low-grade serous ovarian cancer or serous borderline disease
- Major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week before starting treatment
- Current treatment with warfarin unless switched to other anticoagulants
- Inability to swallow oral medications or impaired absorption due to gastrectomy or drainage tubes
- Bowel obstruction within 3 months unless surgically cured or approved
- Symptomatic brain metastases requiring steroids or interventions
- History or signs of retinal or serious ocular diseases increasing risk of retinal vein occlusion
- History of corneal erosion, degeneration, keratitis, or serious ocular surface inflammation
- History of rhabdomyolysis
- Known allergy to study drugs or their inactive ingredients
- Breastfeeding women
- Any medical condition that puts patient at high risk for toxicity as judged by investigator
- Use of medications, supplements, or foods with potential interactions with study drugs within 14 days before treatment and during therapy including strong CYP3A4 or CYP2C9 inhibitors/inducers and P-glycoprotein inhibitors/inducers
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Rachel Grisham, MD
CONTACT
C
Chrisann Kyi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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