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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: Completed Phase 1 study, sponsored by Seagen.
NCT01983501 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01983501 record still lists
NCT01983501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which T-DM1 is the first listed.
NCT01983501 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01983501's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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