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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 28 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01513083
The ClinicalTrials.gov registry entry for NCT01513083 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which trastuzumab emtansine is the first listed.
NCT01513083 reports 0 study locations.
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.
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