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NCT00928330 · ClinicalTrials.gov registry record · Phase 1
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00928330 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 57 participants.
The verdict
NCT00928330, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
Interventions
- DRUG Trastuzumab
- DRUG GDC-0941
- DRUG trastuzumab-MCC-DM1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00928330
The ClinicalTrials.gov registry entry for NCT00928330 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 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 Trastuzumab is the first listed.
NCT00928330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00928330 about?
NCT00928330 is a clinical study titled "Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy". This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
What is the current status of trial NCT00928330?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2009-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00928330?
The interventions under investigation include: Trastuzumab (DRUG), GDC-0941 (DRUG), trastuzumab-MCC-DM1 (DRUG).
Who is sponsoring clinical trial NCT00928330?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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