Study on Neratinib and Valproate for Advanced Solid Tumors, Including Ras-Mutated Cancers

Sponsor: Virginia Commonwealth University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03919292

Provider View

This clinical trial is testing the safety and effectiveness of combining two drugs, neratinib and valproate, in treating advanced solid tumors. The study focuses on tumors with RAS mutations, certain brain cancers, and eye melanoma.

Patient Parameters

Program Overview

The aim of this study is to find the best dose of two drugs, neratinib and valproate, for treating advanced solid tumors. Researchers are particularly interested in how these drugs work on tumors with RAS mutations, a type of brain cancer called EGFR-altered glioblastoma multiforme (GBM), and eye melanoma. The study will first determine the safest dose and then explore how well the drug combination works against these specific cancers.

Description

This trial is designed to test the safety of using two drugs together, neratinib (Nerlynx) and valproate (Depakote DR), in patients with advanced cancer. Initially, the study will focus on finding the right doses of these drugs to use in future research. The trial will also look at how well advanced tumors respond to this drug combination.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor that has worsened after standard treatments or for which no standard treatment exists.
  • For Phase 2, have a RAS-mutated tumor, such as colon or pancreatic cancer, or ocular melanoma.
  • Have measurable disease according to specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate bone marrow, kidney, and liver function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have untreated or symptomatic brain metastases.
  • Have taken any investigational drugs within four weeks before starting the study.
  • Have previously been treated with neratinib.
  • Have uncontrolled diarrhea or difficulty swallowing medication.
  • Have certain heart conditions or low blood pressure.
  • Have active infections or certain liver conditions.
  • Be pregnant or breastfeeding.
  • Have any medical or psychological condition that might interfere with the study.

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