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NCT00951665 · ClinicalTrials.gov registry record · Phase 1
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT00951665 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 107 participants.
The verdict
NCT00951665, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.
Interventions
- DRUG paclitaxel
- DRUG pertuzumab [Perjeta]
- DRUG trastuzumab emtansine [Kadcyla]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00951665
The ClinicalTrials.gov registry entry for NCT00951665 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which paclitaxel is the first listed.
NCT00951665 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00951665 about?
NCT00951665 is a clinical study titled "A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer". This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in pa...
What is the current status of trial NCT00951665?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2009-08. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00951665?
The interventions under investigation include: paclitaxel (DRUG), pertuzumab [Perjeta] (DRUG), trastuzumab emtansine [Kadcyla] (DRUG).
Who is sponsoring clinical trial NCT00951665?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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