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A phase1 Multi-center, Open Label, Dose-escalation Study of Oral LEE011 in Patients With Advanced Solid Tumors or Lymphoma

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Trial Profile

A phase1 Multi-center, Open Label, Dose-escalation Study of Oral LEE011 in Patients With Advanced Solid Tumors or Lymphoma

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Jul 2023

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At a glance

  • Drugs Ribociclib (Primary)
  • Indications Lymphoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 19 Jul 2023 Results of pooled data from NCT01898845, NCT01237236, NCT01872260, NCT01958021,NCT02422615, NCT02278120 to determine PK, safety and efficacy of Ribociclib in combination with endocrine therapy (ET) presented in the Journal of Clinical Pharmacology
    • 18 Jun 2020 Results performing Ribociclib Drug-Drug Interactions and Clinical Evaluations of PBPK Modeling to Guide Drug Labeling, published in the Clinical Pharmacology and Therapeutics
    • 14 Dec 2019 Results characterizing the pharmacokinetics of Ribociclib as a single agent in patients with advanced cancer from this study (NCT01237236) and assessing the potential for drug-drug interactions (DDIs) by comparing steady-state exposures data from this study for Ribociclib alone with those of Ribociclib when used in combination with endocrine therapy from four studies (NCT01872260,NCT01958021,NCT02278120 and NCT02422615), were presented at the 42nd Annual San Antonio Breast Cancer.
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