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)

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2017

At a glance

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

    • 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
    • 26 Oct 2016 Planned End Date changed from 1 Sep 2015 to 1 May 2017.
    • 26 Oct 2016 Planned primary completion date changed from 1 Dec 2014 to 1 May 2017.
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