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NCT02366949

Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel

Completed Phase 1 Last updated 7 April 2020
What this trial tests

Phase 1 trial testing BAY1217389 in Medical Oncology in 75 participants. Completed in 18 April 2019.

Timeline
27 February 2015
Primary endpoint
30 March 2018
18 April 2019

Quick facts

Lead sponsorBayer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment75
Start date27 February 2015
Primary completion30 March 2018
Estimated completion18 April 2019
Sites7 locations across Netherlands, United States

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Medical Oncology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumour treating fields therapy for glioblastoma: current advances and future directions.
    Rominiyi O, Vanderlinden A, Clenton SJ, Bridgewater C, et al · · 2021 · cited 203× · PMID 33144698 · DOI 10.1038/s41416-020-01136-5
  2. Targeting the cell cycle in breast cancer: towards the next phase.
    Thu KL, Soria-Bretones I, Mak TW, Cescon DW. · · 2018 · cited 117× · PMID 30078354 · DOI 10.1080/15384101.2018.1502567
  3. Chromosomal instability sensitizes patient breast tumors to multipolar divisions induced by paclitaxel.
    Scribano CM, Wan J, Esbona K, Tucker JB, et al · · 2021 · cited 107× · PMID 34516829 · DOI 10.1126/scitranslmed.abd4811
  4. The two sides of chromosomal instability: drivers and brakes in cancer.
    Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
  5. APC/C Dysfunction Limits Excessive Cancer Chromosomal Instability.
    Sansregret L, Patterson JO, Dewhurst S, López-García C, et al · · 2017 · cited 96× · PMID 28069571 · DOI 10.1158/2159-8290.cd-16-0645
  6. Functional characterization of CFI-402257, a potent and selective Mps1/TTK kinase inhibitor, for the treatment of cancer.
    Mason JM, Wei X, Fletcher GC, Kiarash R, et al · · 2017 · cited 94× · PMID 28270606 · DOI 10.1073/pnas.1700234114
  7. A link between mitotic defects and mitotic catastrophe: detection and cell fate.
    Sazonova EV, Petrichuk SV, Kopeina GS, Zhivotovsky B. · · 2021 · cited 86× · PMID 34886882 · DOI 10.1186/s13062-021-00313-7
  8. Disruption of the anaphase-promoting complex confers resistance to TTK inhibitors in triple-negative breast cancer.
    Thu KL, Silvester J, Elliott MJ, Ba-Alawi W, et al · · 2018 · cited 72× · PMID 29378962 · DOI 10.1073/pnas.1719577115

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Data sources for this page

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