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NCT03429101 · ClinicalTrials.gov registry record · Phase 1
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
A Phase 1 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03429101: Clinical Trial Phase 1 study, sponsored by Spectrum Pharmaceuticals.
NCT03429101 is a Phase 1 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03429101, a Phase 1 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.
Primary Outcome
Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.
Interventions
- DRUG T-DM1
- DRUG Poziotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-04-17 |
| Phase | Phase 1 |
Why NCT03429101 stopped before completion
NCT03429101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which T-DM1 is the first listed.
NCT03429101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03429101 about?
NCT03429101 is a clinical study titled "A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer". This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The ...
What is the current status of trial NCT03429101?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-07-13. Estimated completion is 2019-04-17.
What interventions are being tested in trial NCT03429101?
The interventions under investigation include: T-DM1 (DRUG), Poziotinib (DRUG).
Who is sponsoring clinical trial NCT03429101?
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 NCT03429101's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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