Actively Recruiting
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
Led by Virginia Commonwealth University · Updated on 2026-04-21
83
Participants Needed
1
Research Sites
613 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
P
Puma Biotechnology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Advanced solid tumor progressed after treatment or no standard effective therapy available (Phase 1 dose escalation)
- Advanced solid tumors with RAS mutation progressed after at least one approved therapy or no standard therapy (Phase 2 expansion), including colon, pancreatic, or other solid tumors
- Ocular melanoma or other cancers with GNAQ or GNA11 mutation
- Measurable disease by RECIST v1.1
- ECOG performance status 0 or 1
- Adequate bone marrow function: ANC 215000/mm3, platelets 2100,000/mm3, hemoglobin E9 g/dL (untransfused)
- Adequate renal function: creatinine 21.5 x ULN or clearance 260 mL/min
- Adequate hepatic function: total bilirubin 21.5 x ULN (with exceptions), AST and ALT 23 x ULN (up to 25 x ULN with liver metastasis)
- Non-hematologic toxicities from prior therapies resolved to 2 grade 1 or stable chronic residuals
- INR 21.5 and aPTT 21.5 x ULN
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Participants must agree to use effective contraception during and 2 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Known meningeal or symptomatic/untreated brain metastases (stable treated brain metastases allowed)
- Use of any investigational agent within 4 weeks before treatment
- Previous neratinib therapy
- Active uncontrolled diarrhea causing dehydration or electrolyte issues
- Inability to swallow medication
- Known or suspected malabsorption or obstruction (pancreatic enzyme supplements allowed)
- Inability to adjust medications: antacids, H2 blockers relative to neratinib dosing
- Resting systolic blood pressure below 100 mmHg
- Active or significant cardiac disease including unstable angina, recent myocardial infarction, arrhythmias needing treatment (except beta blockers), or severe heart failure
- Seizure disorder requiring enzyme-inducing antiepileptic drugs
- Serious uncontrolled infection
- Chronic or active hepatitis B or C with elevated liver enzymes
- Pleural effusion or ascites causing breathing problems
- Known mitochondrial or urea cycle disorders
- Planned treatment with drugs that interact adversely with study medications (certain cosyntropin, PPIs, P-glycoprotein substrates, CYP3A4 inhibitors/inducers)
- Pregnancy or breastfeeding
- Medical, psychological, or social conditions that may increase risk or limit adherence to study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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