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NCT03804515 · ClinicalTrials.gov registry record · Phase 1
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib
A Phase 1 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT03804515: Clinical Trial Phase 1 study, sponsored by Spectrum Pharmaceuticals.
NCT03804515 is a Phase 1 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03804515, a Phase 1 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
Primary Outcome
The route of excretion of radioactive poziotinib and its metabolites following single oral administration of 14C-labeled poziotinib in patients with solid tumors suitable for treatment with poziotinib.
Interventions
- DRUG 14C-labeled poziotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2020-06-17 |
| Phase | Phase 1 |
Why NCT03804515 stopped before completion
NCT03804515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which 14C-labeled poziotinib is the first listed.
NCT03804515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03804515 about?
NCT03804515 is a clinical study titled "A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib". The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.
What is the current status of trial NCT03804515?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2019-06-25. Estimated completion is 2020-06-17.
What interventions are being tested in trial NCT03804515?
The interventions under investigation include: 14C-labeled poziotinib (DRUG).
Who is sponsoring clinical trial NCT03804515?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03804515's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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