Trials / Completed
CompletedNCT00932373
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trastuzumab-MCC-DM1 | Intravenous escalating dose |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2009-07-03
- Last updated
- 2015-08-26
- Results posted
- 2015-07-30
Source: ClinicalTrials.gov record NCT00932373. Inclusion in this directory is not an endorsement.