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Identification of Treatment Concentrations of Defactinib or Avutometinib for the Treatment of Patients with Glioblastoma


Active: Yes
Cancer Type: Brain & Spinal Cord Tumor NCT ID: NCT05798507
Trial Phases: Protocol IDs: WINSHIP5751-22 (primary)
NCI-2023-00602
STUDY00004876
Eligibility: 21 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Emory University Hospital/Winship Cancer Institute
NCI Full Details: http://clinicaltrials.gov/show/NCT05798507

Summary

This early phase I trial tests brain concentration level and safety of defactinib or avutometinib for the treatment of patients with glioblastoma. Recently, two new drugs that seem to work together have been shown to have promising treatment effects in tissue culture and animal models of glioblastoma. Each inhibits a different glioblastoma growth pathway and when used together may create a larger effect on tumor growth than either alone. Growth pathway describes a series of chemical reactions in which a group of molecules in a cell work together to control cell growth. It is known that glioblastoma tumor cells can grow because of lack of regulation. Both Pyk2 and the closely related kinase (FAK) proteins help regulate tumor cell invasion, unless they are produced in large amounts (over expressed). Specifically, Raf and FAK/Pyk2 regulation of cell division is activated quite a bit more in gliomas compared to normal tissues. Recently developed inhibitors of Raf (avutometinib) and FAK (defactinib) which belong to a class of medications called kinase inhibitors, are aimed to bring their activity to proper levels and may stop tumor growth.

Objectives

PRIMARY OBJECTIVES:
I. Estimate (or characterize) the concentration of defactinib or avutometinib that accumulates in the glioblastoma (GBM) and brain around tumor.
II. Assess the safety of the administration of a single oral dose of defactinib or avutometinib in patients with glioblastoma.
III. Assess the inhibition of Pyk2/FAK or MEK, Erk signaling in tumor and brain around tumor.
IV. Assess the pharmacodynamics of defactinib or avutometinib in patients with glioblastoma.

OUTLINE: This is a dose-escalation study of defactinib and avutometinib. Patients are assigned to 1 of 2 arms.

ARM I: Patients receive 1 dose of defactinib orally (PO) while on study, prior to planned tumor resection. Patients undergo echocardiography at screening and undergo blood collection and donate resected tumor tissue while on study.

ARM II: Patients receive 1 dose of avutometinib PO while on study, prior to planned tumor resection. Patients undergo echocardiography at screening and undergo blood collection and donate resected tumor tissue while on study.

Patients follow up at 2 weeks post surgery.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.