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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 is a Phase 1 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03429101
The ClinicalTrials.gov registry entry for NCT03429101 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which T-DM1 is the first listed.
NCT03429101 reports 0 study locations.
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.
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