An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies.

Trial Profile

An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies.

Completed
Phase of Trial: Phase I

Latest Information Update: 02 May 2017

At a glance

  • Drugs Roniciclib (Primary)
  • Indications Ovarian cancer; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 02 May 2017 Results assessing safety and efficacy of two dosing schedules (3 days on/4 days off or 4 weeks on/2 weeks off) in two trials (NCT01188252 and NCT01335256), published in the British Journal of Cancer
    • 06 Jan 2017 Status changed from active, no longer recruiting to completed.
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