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NCT03458728 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03458728: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT03458728 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03458728, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
Primary Outcome
Maximum tolerated dose (MTD) for copanlisib was defined as the highest dose level where 6 patients have been treated and ≤ 1 participant experienced a DLT. This endpoint was performed on SAF.
Interventions
- DRUG Copanlisib (BAY806946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2023-02-01 |
| Phase | Phase 1 |
Why NCT03458728 stopped before completion
NCT03458728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Copanlisib (BAY806946) is the first listed.
NCT03458728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03458728 about?
NCT03458728 is a clinical study titled "Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients". This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
What is the current status of trial NCT03458728?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2018-04-30. Estimated completion is 2023-02-01.
What interventions are being tested in trial NCT03458728?
The interventions under investigation include: Copanlisib (BAY806946) (DRUG).
Who is sponsoring clinical trial NCT03458728?
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 NCT03458728's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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