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A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia.

Trial Profile

A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Idasanutlin (Primary)
  • Indications Cancer; Chondrosarcoma; Colorectal cancer; Leiomyosarcoma; Malignant melanoma; Mesothelioma; Sarcoma; Testicular cancer
  • Focus Adverse reactions; First in man
  • Sponsors Roche
  • Most Recent Events

    • 28 Jun 2021 Results assessing maximum tolerated dose (MTD), characterize dose-limiting toxicity (DLT), and explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical responses with idasanutlin with different dosing schedules published in the Investigational New Drugs
    • 08 Dec 2020 Results investigating the contribution of Idasanutlin exposure variability to those findings, in particular, the relationship between exposure and toxicity and efficacy in pts with AML from NCT02545283, NCT01773408, NCT01462175 and NCT03287245 presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
    • 04 Aug 2014 According to the ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
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