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An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies

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An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs BAY 1217389 (Primary) ; BAY 1217389 (Primary) ; Paclitaxel
  • Indications Adenocarcinoma; Advanced breast cancer; Cholangiocarcinoma; Gastric cancer; Male breast cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Small cell lung cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Bayer

    • Most Recent Events

    • 13 Sep 2021 Results assessing combination of BAY with paclitaxel using a novel randomized continuous reassessment method (rCRM) to improve dose determinationpublished in the Clinical Cancer Research
    • 03 May 2019 Status changed from active, no longer recruiting to completed.
    • 20 Nov 2018 Planned End Date changed from 28 Dec 2018 to 28 Jun 2019.

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