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NCT01411410 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With Paclitaxel in Patients With Advanced Cancer
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01411410 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 55 participants.
The verdict
NCT01411410, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple participating sites from the US. Following determination of the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16 patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified dosing) in which another 20 subjects are planned to be enrolled to treatment.
Interventions
- DRUG Paclitaxel
- DRUG Copanlisib (BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-08-24 |
| Est. Completion | 2015-06-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01411410
The ClinicalTrials.gov registry entry for NCT01411410 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01411410 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01411410 about?
NCT01411410 is a clinical study titled "Phase I Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With Paclitaxel in Patients With Advanced Cancer". This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple parti...
What is the current status of trial NCT01411410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-08-24. Estimated completion is 2015-06-29.
What interventions are being tested in trial NCT01411410?
The interventions under investigation include: Paclitaxel (DRUG), Copanlisib (BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT01411410?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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