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NCT02138812 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT02138812: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT02138812 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138812, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced malignancies.
Primary Outcome
MTD is defined as the highest dose of oral BAY1161909 (administered in combination with or without IV paclitaxel) that can be given such that not more than 30% of the subjects experience a dose-limiting toxicity (DLT) during Cycles 1 and 2. The safety profile of oral BAY1161909 will first be determined in combination with 75 mg/m\^2 IV paclitaxel \[MTD (75)\]. Starting in \>Cohort 7 (12 mg 2 times daily \[BID\] BAY1161909) the MTD of oral BAY1161909 will then be refined for the combination with
Interventions
- DRUG Paclitaxel
- DRUG BAY1161909
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-05-09 |
| Est. Completion | 2017-10-02 |
| Phase | Phase 1 |
Why NCT02138812 stopped before completion
NCT02138812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT02138812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02138812 about?
NCT02138812 is a clinical study titled "Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel". Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced malignancies.
What is the current status of trial NCT02138812?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2014-05-09. Estimated completion is 2017-10-02.
What interventions are being tested in trial NCT02138812?
The interventions under investigation include: Paclitaxel (DRUG), BAY1161909 (DRUG).
Who is sponsoring clinical trial NCT02138812?
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 NCT02138812's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 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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