Trial · NCT02366949
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
NCT02366949, Phase 1, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel. Trials, record NCT02366949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02366949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
- NCT number
- NCT02366949
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 75 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Medical Oncology
- Interventions
- BAY1217389, Paclitaxel
- First posted
- 2015-02-19
- Last updated
- 2020-04-07
- Other registries' IDs
- eudract:2014-004821-41
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | Up to 28 days (Cycle 1) | The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort. |
| Primary | Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability. | After the first study drug administration and up to 30 days after the end of treatment with study drug before primary completion analysis of the study, up to 3 years | |
| Primary | Maximum observed drug concentration (Cmax) of BAY1217389 in plasma | From pre-dose up to 96 hours post-dose on C1D-8 and C1D-4; from pre-dose up to 12 hours post-dose on C1D8 and C1D9 | |
| Primary | Area under the concentration versus time curve from zero to 12 hours (AUC [0-12]) of BAY1217389 in plasma | From pre-dose up to 12 hours post-dose on C1D-4, C1D8 and C1D9 | |
| Primary | Area under the concentration versus time curve from zero to 96 hours (AUC [0-96]) of BAY1217389 in plasma | From pre-dose up to 96 hours post-dose on C1D-4 | |
| Primary | Maximum observed drug concentration (Cmax) of paclitaxel in plasma | From pre-dose up to 24 hours post-dose on C1D1 and C1D8 | |
| Primary | Area under the concentration versus time curve from zero to infinity (AUC) of paclitaxel in plasma | From pre-dose up to 24 hours post-dose on C1D1 and C1D8 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02366949
GET https://conductscience.org/api/trials/v1/NCT02366949/registered