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Clinical Trial 21119

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04625270

Phase: Phase II
Principal Investigator: Chon, Hye Sook

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Summary

This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Objective

Primary Objectives (Parts A and B) Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B). Part B: To determine the efficacy of the optimal regimen identified from Part A. Secondary Objectives (Parts A and B) To characterize the safety and toxicity profile of VS-6766 as a monotherapy and in combination with defactinib in LGSOC. Part A: To evaluate additional efficacy parameters for VS-6766 monotherapy and in combination with defactinib. Part B: To evaluate additional efficacy parameters for the optimal regimen identified in Part A. To characterize the pharmacokinetics (PK) of VS-6766, defactinib, and relevant metabolites.

Treatments

Therapies

Therapy (NOS)

Medications

Defactinib (VS-6063); VS-6766 ()

Inclusion Criteria

Histologically proven LGSOC (ovarian, peritoneal)

Tumor with known KRAS mutational status using a validated testing method (blood or tissue) prior to treatment assignment. Adequate material as defined in the lab manual must be available for central confirmation prior to treatment assignment.

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 > Adequate organ function

Adequate recovery from toxicities related to prior treatments

Female patients with reproductive potential agree to use highly effective method of contraceptive (per Clinical Trial Facilitation Group [CFTG] recommendations during trial and for 1 month following the last dose of study intervention.

Other criteria may apply

Exclusion Criteria

Systemic anti-cancer therapy within 4 weeks of the first dose of study intervention

Co-existing high-grade ovarian cancer or another histology

History of prior malignancy with recurrence > Patients who are deemed in the opinion of the treating physician to be appropriate candidates for a debulking surgery. These patients should preferentially receive surgery prior to consideration of trial therapy.

Major surgery within 4 weeks

Treatment with warfarin. Patients on warfarin for deep vein thrombosis/pulmonary embolism can be converted to low-molecular-weight heparin or direct oral anticoagulants (DOACs)

Exposure to medications (with or without prescription) supplements, herbal remedies, or foods with potential for drug-drug interactions with study intervention and during the course of therapy.

Symptomatic brain metastases requiring steroids or other interventions

Known severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection (clinical symptoms) > For patients 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

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