A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Oklahoma
Study ID
NCT05512208
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Cancer
  • Endometrioid Cancer
  • High Grade Serous Ovarian Cancer
  • Mucinous Ovarian Cancer
  • Solid Tumor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Avutometinib (VS-6766) + defactinib — DRUG
    Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID). Treatment will be for 3 weeks, followed by a 1-week rest period, in each 4-week (28 day) cycle.

Study Details

The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or solid gynecological cancer.

Key Dates

Start date
Feb 6, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Avutometinib (VS-6766) + Defactinib
    Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID).

Primary Outcome Measure

Proportion of Patients with objective response rate [ Time Frame: 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
AdventHealthOrlandoFlorida32804
Robert Holloway, MD
[email protected]
407-303-2422
Robert Holloway, MD (PRINCIPAL_INVESTIGATOR)
Louisiana State University Medical Center New OrleansNew OrleansLouisiana70112
Tara Castellano, MD
[email protected]
504-568-4850
Tara Castellano, MD (PRINCIPAL_INVESTIGATOR)
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131
Carolyn Muller, MD
[email protected]
505-925-0460
Carolyn C Muller, MD (PRINCIPAL_INVESTIGATOR)
Stephenson Cancer CenterOklahoma CityOklahoma73117
SCC IIT Office
[email protected]
405-271-8777

Find similar trials in Orlando, FL

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
AdventHealth· Orlando, FLLouisiana State University Medical Center New Orleans· New Orleans, LAUniversity of New Mexico Comprehensive Cancer Center· Albuquerque, NMStephenson Cancer Center· Oklahoma City, OK

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