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Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma

NCT02068586 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-16

No results posted yet for this study

Summary

This randomized phase II trial studies how well sunitinib malate or valproic acid works in preventing high-risk uveal (eye) melanoma from spreading to other parts of the body. Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents these cells from growing. Valproic acid may change the expression of some genes in uveal melanoma and suppress tumor growth.

Conditions

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Ciliary Body and Choroid Melanoma, Small Size
  • Iris Melanoma
  • Stage I Intraocular Melanoma
  • Stage IIA Intraocular Melanoma
  • Stage IIB Intraocular Melanoma
  • Stage IIIA Intraocular Melanoma
  • Stage IIIB Intraocular Melanoma
  • Stage IIIC Intraocular Melanoma
  • Stage I Uveal Melanoma AJCC V7
  • Stage II Uveal Melanoma AJCC V7
  • Stage III Uveal Melanoma AJCC V7

Interventions

DRUG

Sunitinib

Given PO

DRUG

Valproic Acid

Given PO

DRUG

Sunitinib Malate

Given PO

DRUG

Sunitinib Malate + Valproic Acid

Given PO

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Takami Sato, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-19
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068586 on ClinicalTrials.gov