OncoMatch/Clinical Trials/NCT03919292
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
Is NCT03919292 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Neratinib and Divalproex Sodium for solid tumor, adult.
Treatment: Neratinib · Divalproex Sodium — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: GNA11 mutation
Required: GNAQ mutation
Required: HRAS mutation
Required: KRAS mutation
Required: NRAS mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: approved therapy
has progressed during or after treatment with at least one approved therapy or for which there is no standard effective therapy available
Cannot have received: neratinib (neratinib)
Previous therapy with neratinib
Cannot have received: investigational agent
Any investigational agent within 4 weeks prior to initiating study treatment
Lab requirements
Blood counts
ANC ≥ 1500/mm3; platelets ≥ 100,000/mm3; hemoglobin > 9 g/dL (untransfused)
Kidney function
Creatinine ≤ 1.5 x ULN or calculated/actual creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (exception: Gilbert's syndrome if direct bilirubin WNL); AST/ALT ≤ 3.0 x ULN (≤ 5 x ULN with liver metastasis)
Cardiac function
No unstable angina, recent MI (within 6 months), arrhythmias requiring anti-arrhythmic therapy (other than beta blockers), or NYHA class III/IV CHF; resting systolic BP ≥ 100 mmHg
Adequate bone marrow function...Adequate renal function...Adequate hepatic function...Active or clinically significant cardiac disease including any of the following: Unstable angina...Myocardial infarction diagnosed within 6 months...Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers...NYHA class III or IV congestive heart failure...Resting systolic blood pressure (BP) < 100 mmHg [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Virginia Commonwealth University Massey Cancer Center · Richmond, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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