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NCT00807859 · ClinicalTrials.gov registry record · Phase 1
Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00807859 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 65 participants.
The verdict
NCT00807859, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.
Interventions
- DRUG AMG 386 30 mg/kg, Paclitaxel and Trastuzumab
- DRUG AMG 386 30 mg/kg, Capecitabine and Lapatinib
- DRUG AMG 386 10 mgkg, Paclitaxel and Trastuzumab
- DRUG AMG 386 10 mg/kg, Capecitabine and Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2009-03-09 |
| Est. Completion | 2015-10-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00807859
The ClinicalTrials.gov registry entry for NCT00807859 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which AMG 386 30 mg/kg, Paclitaxel and Trastuzumab is the first listed.
NCT00807859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00807859 about?
NCT00807859 is a clinical study titled "Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer". The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study part...
What is the current status of trial NCT00807859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2009-03-09. Estimated completion is 2015-10-19.
What interventions are being tested in trial NCT00807859?
The interventions under investigation include: AMG 386 30 mg/kg, Paclitaxel and Trastuzumab (DRUG), AMG 386 30 mg/kg, Capecitabine and Lapatinib (DRUG), AMG 386 10 mgkg, Paclitaxel and Trastuzumab (DRUG), AMG 386 10 mg/kg, Capecitabine and Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00807859?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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