RecruitingPhase 1Phase 2NCT03919292

Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers

Sponsor

Virginia Commonwealth University

Enrollment

83 participants

Start Date

May 1, 2019

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult

Summary

To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors. Then to explore the antitumor effects of the neratinib and sodium valproate combination in advanced solid tumors with attention to RAS-mutated tumors, EGFR-altered GBM, and ocular melanoma, as part of the phase 2 expansion cohort.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of neratinib (a cancer signaling blocker) and valproate (a drug used for epilepsy that can also affect cancer cells) in people with advanced solid tumors, with a focus on RAS-mutated cancers in the expansion phase. **You may be eligible if...** - You have an advanced solid tumor that has progressed after standard treatment, or for which no standard treatment exists - In the expansion phase: your cancer has a RAS mutation and is colon cancer, pancreatic cancer, ocular melanoma, or another qualifying solid tumor - Your disease is measurable on imaging and you are in adequate overall health (ECOG 0-2) **You may NOT be eligible if...** - Your cancer does not meet the RAS mutation or tumor type criteria for the expansion phase - Your organ function is below the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeratinib

Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion). Doses of Neratinib are escalated in small groups of patients during the dose expansion portion of the study.

DRUGDivalproex Sodium

Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion).