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NCT01460537 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01460537 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 50 participants.
The verdict
NCT01460537, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This open label Phase I study involves treating subjects with advanced cancer with Copanlisib in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination with gemcitabine and Copanlisib in combination with cisplatin and gemcitabine. The trial will involve multiple participating sites from the US. Up to a maximum of 70 subjects will be enrolled in the study.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG NaCl
- DRUG BAY80-6946
- DRUG BAY80-6964 fixed dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-11-18 |
| Est. Completion | 2015-12-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01460537
The ClinicalTrials.gov registry entry for NCT01460537 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 5 interventions - of which Cisplatin is the first listed.
NCT01460537 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01460537 about?
NCT01460537 is a clinical study titled "Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer". This open label Phase I study involves treating subjects with advanced cancer with Copanlisib in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination with gemcitabine and...
What is the current status of trial NCT01460537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-11-18. Estimated completion is 2015-12-18.
What interventions are being tested in trial NCT01460537?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), NaCl (DRUG), BAY80-6946 (DRUG), BAY80-6964 fixed dose (DRUG).
Who is sponsoring clinical trial NCT01460537?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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