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NCT01983501 · ClinicalTrials.gov registry record · Phase 1
A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT01983501 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 57 participants.
The verdict
NCT01983501, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
Interventions
- DRUG T-DM1
- DRUG Tucatinib (ONT-380)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-02-28 |
| Est. Completion | 2020-09-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01983501
The ClinicalTrials.gov registry entry for NCT01983501 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 84 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.
NCT01983501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01983501 about?
NCT01983501 is a clinical study titled "A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer". The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
What is the current status of trial NCT01983501?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2014-02-28. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT01983501?
The interventions under investigation include: T-DM1 (DRUG), Tucatinib (ONT-380) (DRUG).
Who is sponsoring clinical trial NCT01983501?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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