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A Single-Center, Open-label, 2-period, non-fasting study to evaluate the effect of Azithromycin on Venetoclax Pharmacokinetics in Healthy Female Volunteers

Trial Profile

A Single-Center, Open-label, 2-period, non-fasting study to evaluate the effect of Azithromycin on Venetoclax Pharmacokinetics in Healthy Female Volunteers

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 19 Mar 2019

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At a glance

  • Drugs Venetoclax (Primary) ; Azithromycin
  • Indications Acute myeloid leukaemia; Breast cancer; Cancer; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Multiple myeloma; Myelodysplastic syndromes; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma; Systemic lupus erythematosus; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 19 Mar 2019 Status changed from completed to suspended according to an Abbvie media release.
    • 19 Mar 2019 According to an AbbVie media release, the company announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from BELLINI study.As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed
    • 08 Oct 2018 New trial record
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