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NCT02366949
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
Phase 1 trial testing BAY1217389 in Medical Oncology in 75 participants. Completed in 18 April 2019.
30 March 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 27 February 2015 |
| Primary completion | 30 March 2018 |
| Estimated completion | 18 April 2019 |
| Sites | 7 locations across Netherlands, United States |
Drugs / interventions tested
- BAY1217389 — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Medical Oncology — all drugs for Medical Oncology →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT02366949
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02366949 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 7 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02366949.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing