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Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)

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Trial Profile

Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 10 Aug 2022

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At a glance

  • Drugs Fulvestrant (Primary) ; NUV-422 (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NUV-422-03
  • Sponsors Nuvation Bio

    • Most Recent Events

    • 02 Aug 2022 Status changed from discontinued to withdrawn prior to enrolment on Sponsor decision.
    • 01 Aug 2022 Status changed from suspended to discontinued, according to a Nuvation Bio media release.
    • 01 Aug 2022 According to a Nuvation Bio media release, company discontinued clinical development of NUV-422.The decision is the result of an internal risk-benefit analysis factoring in feedback received from the U.S. Food and Drug Administration (FDA) in a partial clinical hold letter for the for NUV-422-02 and clinical hold letters for NUV-422-03 and NUV-422-04 studies.

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