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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

PHASE2RECRUITING

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma.

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Study details:

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
  • Able to dose orally
  • ECOG Performance status of 0-1
  • No other significant underlying ocular disease
  • Adequate organ function
  • Not pregnant/nursing or planning to become pregnant. Willing to use birth control
  • Exclusion criteria

  • Previous treatment with a Protein Kinase C (PKC) inhibitor
  • Concurrent malignant disease
  • Active HIV infection or Hep B/C
  • Malabsorption disorder
  • Unable to discontinue prohibited medication
  • Impaired cardiac function or clinically significant cardiac disease
  • Any other condition which may interfere with study interpretation or results
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-07-03

    Primary completion: 2026-01-31

    Study completion finish: 2029-01-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05907954

    Intervention or treatment

    DRUG: Darovasertib

    Conditions

    • Uveal Melanoma

    Find a site

    Closest Location:

    Alfred Health

    Research sites nearby

    Select from list below to view details:

    • Alfred Health

      Melbourne, Victoria, Australia

    • St. Vincent's Health Sydney

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: darovasertib
    • IDE196 (darovasertib) oral open label
    DRUG: Darovasertib
    • Oral, potent, selective inhibitor of Protein Kinase C

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of Adverse Events (AEs) and significant laboratory abnormalitiesTreatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.from first dose to last dose of adjuvant therapy, approximately 12 months
    Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiationRate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapyfrom first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
    Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation doseChange in modeled radiation dose at critical eye structures before and after neoadjuvant therapyfrom first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Evaluate tumor response to neoadjuvant IDE196Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters)from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
    Assessment of visual acuity lossBest corrected visual acuity loss over timefrom time of primary local therapy to one year after surgery, approximately 12 months
    Rate of local disease recurrenceEvaluate uveal melanoma progression or recurrencefrom date of primary local therapy to end of follow-up, approximately 36 months
    Rate of metastatic diseaseEvaluate occurrence of metastatic uveal melanomafrom date of primary local therapy to end of follow-up, approximately 36 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

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