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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v20
  2. Minor Re-verified, no change to tracked fieldsv19
  3. Notable Primary and study completion dates: Dec 30, 2023 to Dec 31, 2025
    • Collaborators: 2 to 1
    v18
  4. Notable Primary and study completion dates: Jun 30, 2023 to Dec 30, 2023v17
  5. Notable Primary completion date: Dec 31, 2022 to Jun 30, 2023v16 Show 9 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 150 to 210
    • Interventions: Sunitinib (Drug), Valproic Acid (Drug) to Sunitinib (Drug), Sunitinib Malate (Drug), Sunitinib Malate + Valproic Acid (Drug), Valproic Acid (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 2 to 5
    • Study description expanded, about 190 words
    • Collaborators: 1 to 2
    • Study arms: 2 to 4
    • Study title expanded, about 3 words
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2022 to Jun 30, 2023
    • Site details revised
    v15
  2. Notable Primary completion date: Dec 2020 to Dec 31, 2021
    • Study completion date: Dec 2021 to Jul 2022
    v14
  3. Minor Re-verified, no change to tracked fieldsv13
  4. Notable Primary completion date: Feb 2019 to Dec 2020
    • Study completion date: Feb 2020 to Dec 2021
    v12
  5. Notable Enrollment target: 90 to 150v11
  6. Minor Study completion date: Feb 2020
    • Start date: Nov 2014 to Nov 19, 2014
    • Study site revised
    v10
  7. Notable Lead sponsor: Thomas Jefferson University to Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson Universityv9
  8. Minor 3 versions Re-verified since Jun 30, 2015, no change to tracked fieldsv6-v8
  9. Minor Site contact updatedv5
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2014 to Nov 2014
    • Site details revised
    v4
  11. Minor Re-verified, no change to tracked fieldsv3
  12. Minor Start date: Mar 2014v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02068586
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators: Pfizer
Conditions
(from sponsor)
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 +4 more
Related terms Uveal Melanoma
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov