Clinical trialPhase 1 / Phase 2Suspended
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
- Outcome
- Stopped earlyPending amendment approval (Other)
- Phase
- Phase 1 / Phase 2
- Status
- Suspended
- Study type
- Interventional
- Start
- 1 May 2019
- Expected end
- 31 January 2031
- Enrollment
- 80 participants
- Sites
- 1
- Primary outcomes
- Determination of Recommended Phase 2 Dose (RP2D)
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 21 October 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
The purpose of this trial is to test the safety of combining 2 drugs, neratinib (Nerlynx) and divalproex sodium (Depakote DR), also commonly called valproate, when treating patients with advanced cancer. In an earlier stage of this trial the purpose was to test different doses of neratinib in combination with divalproex sodium to see which doses should be used in future research trials. This trial will also help us to learn how advanced tumors respond to the combination of neratinib and divalproex sodium.