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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT03919292
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neratinib + Divalproex Sodium - Dose Escalation Cohort
    Neratinib by mouth (PO) once daily + Divalproex Sodium (Valproate) by mouth (PO) twice daily on days 1-28 of each course.
  • Experimental: Colon
    Colon Cancer (RAS-mutated) - Phase II dose expansion at recommended phase II dose (RP2D)
  • Experimental: Glioblastoma (GBM)
    Glioblastoma with a RAS-mutation or EGFR alteration at RP2D
  • Experimental: Ocular Melanoma (OM)
    Phase II dose expansion at RP2D
  • Experimental: Other Cancer
    "Other Cancer" (RAS-mutated) at RP2D
  • Experimental: Pancreatic Cancer
    RAS-mutated pancreatic cancer at RP2D

Primary Outcome Measure

Determination of Recommended Phase 2 Dose (RP2D) [ Time Frame: 28 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
Massey CTO Phase I Solid Team
[email protected]
804-628-6430
Massey
Andrew Poklepovic, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By research site
Virginia Commonwealth University Massey Cancer Center· Richmond, VA

Related Studies