A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Selumetinib Given Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers

Trial Profile

A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Selumetinib Given Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 10 Mar 2017

At a glance

  • Drugs Selumetinib (Primary)
  • Indications Acute myeloid leukaemia; Biliary cancer; Colorectal cancer; Liver cancer; Malignant melanoma; Multiple myeloma; Non-small cell lung cancer; Pancreatic cancer; Thyroid cancer
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 10 Mar 2017 Results of pooled analysis of ten phase I studies including this study published in the European Journal of Clinical Pharmacology
    • 11 Oct 2016 Results of pooled analysis of PK data from this and other 9 trials (NCT01635023, NCT01974349, NCT02056392, NCT02322749, NCT02238782, NCT02063204, NCT02063230, NCT02093728, NCT02046850) presented at the 41st European Society for Medical Oncology Congress
    • 30 May 2014 Planned number of patients changed from 54 to 117 as reported by ClinicalTrials.gov.
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