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NCT02366949 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT02366949: Completed Phase 1 study, sponsored by Bayer.
NCT02366949 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366949, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Paclitaxel
- DRUG BAY1217389
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2015-02-27 |
| Est. Completion | 2019-04-18 |
| Phase | Phase 1 |
What the finished NCT02366949 record still lists
NCT02366949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT02366949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02366949 about?
NCT02366949 is a clinical study titled "Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel". 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.
What is the current status of trial NCT02366949?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2015-02-27. Estimated completion is 2019-04-18.
What interventions are being tested in trial NCT02366949?
The interventions under investigation include: Paclitaxel (DRUG), BAY1217389 (DRUG).
Who is sponsoring clinical trial NCT02366949?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02366949's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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