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NCT03919292 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, Adult, sponsored by Virginia Commonwealth University.

Recruiting
Registry status
Phase 1
Development phase
83
Enrollment target
1
Study location

NCT03919292 is a Phase 1 study of Solid Tumor, Adult that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 83 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03919292, a Phase 1 study of Solid Tumor, Adult, is actively recruiting participants, sponsored by Virginia Commonwealth University.

RECRUITING
Registry status
Phase 1
Development phase
83 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Neratinib
  • DRUG Divalproex Sodium

Study Locations (1)

Virginia

  • Virginia Commonwealth University Massey Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2019-05-01
Est. Completion 2027-05-31
Phase Phase 1

Sponsor

Virginia Commonwealth University

558 total trials

What the Registry Record Tells You About NCT03919292

The ClinicalTrials.gov registry entry for NCT03919292 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (56% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor, Adult appearing as the primary indexed condition, and to 2 interventions - of which Neratinib is the first listed.

NCT03919292 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT03919292 about?

NCT03919292 is a clinical study titled "Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca". 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 tumo...

What is the current status of trial NCT03919292?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2019-05-01. Estimated completion is 2027-05-31.

What conditions does trial NCT03919292 study?

This clinical trial studies the following conditions: Solid Tumor, Adult.

What interventions are being tested in trial NCT03919292?

The interventions under investigation include: Neratinib (DRUG), Divalproex Sodium (DRUG).

Who is sponsoring clinical trial NCT03919292?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03919292 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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