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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: Completed Phase 1 study, sponsored by Genentech.
NCT00951665 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
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 |
What the finished NCT00951665 record still lists
NCT00951665 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 3 interventions - of which paclitaxel is the first listed.
NCT00951665 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00951665's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 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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