Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02253420 · ClinicalTrials.gov registry record · Phase 1
COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02253420: Completed Phase 1 study, sponsored by Bayer.
NCT02253420 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02253420, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
Primary Outcome
AUC (0-168): Area under the curve from dosing to 168 h after dosing
Interventions
- DRUG Rifampin
- DRUG Itraconazole
- DRUG Copanlisib (BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-10-08 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 1 |
What the finished NCT02253420 record still lists
NCT02253420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT02253420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02253420 about?
NCT02253420 is a clinical study titled "COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients". To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946). To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
What is the current status of trial NCT02253420?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2014-10-08. Estimated completion is 2019-08-13.
What interventions are being tested in trial NCT02253420?
The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Copanlisib (BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT02253420?
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 NCT02253420's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02701153 · 51 participants · NA
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
- NCT03663790 · 51 participants · NA
Effects of Gait Retraining on Lower Extremity Biomechanics
- NCT03874052 · 51 participants · Phase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT04704661 · 51 participants · Phase 1
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI