A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06394804
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Low-Grade Serous Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avutometinib — DRUG
    Starting Dose 3.2 mg BIW for 3 of 4 weeks, Dose -1, 2.4 mg BIW for 3 of 4 weeks
  • Defactinib — DRUG
    Starting Dose 200 mg BID for 3 of 4 weeks, Dose -1, 200 mg QD for 3 of 4 weeks
  • Letrozole — DRUG
    2.5 mg PO daily

Study Details

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.

Key Dates

Start date
Apr 29, 2024
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avutometinib, Defactinib, and Letrozole
    Enrolled patients will be treated with avutometinib 3.2 mg PO, twice weekly (e.g. M/Th,Tu/F, or W/Sa) + defactinib 200 mg PO BID for 3 weeks, followed by a 1 week rest period, in each 4-week (28 day) cycle. Patients will also be treated with letrozole 2.5 mg PO daily, and pre/perimenopausal patients will also receive leuprolide acetate 3.75 mg IM every 4 weeks or 11.25 mg every 3 months for ovarian suppression while an ovary remains in situ.

Primary Outcome Measure

objective response rate [ Time Frame: 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Emory Winship Cancer InstituteAtlantaGeorgia30322
Beryl Manning-Geist, MD
404-778-3401
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Rachel Grisham, MD
646-888-4653
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Rachel Grisham, MD
646-888-4653
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Rachel Grisham, MD
646-888-4653
Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)CommackNew York11725
Rachel Grisham, MD
646-888-4653
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Rachel Grisham, MD
646-888-4653
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Rachel Grisham, MD
646-888-4653
Chrisann Kyi, MD
646-888-4221
Rachel Grisham, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Rachel Grisham, MD
646-888-4653

Find similar trials in Atlanta, GA

By research site
Emory Winship Cancer Institute· Atlanta, GAMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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