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A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients With Advanced Malignancies, Including Acute Myeloid Leukemia (AML)

Trial Profile

A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients With Advanced Malignancies, Including Acute Myeloid Leukemia (AML)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 May 2018

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At a glance

  • Drugs RG 7775 (Primary)
  • Indications Acute myeloid leukaemia; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Roche
  • Most Recent Events

    • 16 May 2018 Status changed from active, no longer recruiting to completed.
    • 25 Oct 2017 Results (n=26) of Arm B assessing safety, PK, PD, and activity of RO6839921 in patients with relapsed/refractory acute myeloid leukaemia, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017.
    • 02 Dec 2016 Results of pk, pd and safety parameter in patients with advanced solid tumors (n=41) presented at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
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