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NCT01513083 · ClinicalTrials.gov registry record · Phase 1
A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01513083: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01513083 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01513083, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Interventions
- DRUG trastuzumab emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT01513083 record still lists
NCT01513083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which trastuzumab emtansine is the first listed.
NCT01513083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01513083 about?
NCT01513083 is a clinical study titled "A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function". This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Antici...
What is the current status of trial NCT01513083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01513083?
The interventions under investigation include: trastuzumab emtansine (DRUG).
Who is sponsoring clinical trial NCT01513083?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01513083's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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