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NCT01434303 · ClinicalTrials.gov registry record · Phase 1
Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01434303: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01434303 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01434303, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of entinostat when given together with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes or has recurred (come back) at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected. Entinostat and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving entinostat together with lapatinib ditosylate and trastuzumab may kill more tumor cells.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Entinostat
- BIOLOGICAL Trastuzumab
- DRUG Lapatinib Ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2012-01-10 |
| Est. Completion | 2016-02-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01434303
The ClinicalTrials.gov registry entry for NCT01434303 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01434303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01434303 about?
NCT01434303 is a clinical study titled "Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only". This phase I trial studies the side effects and best dose of entinostat when given together with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes or has recurred (come back) at or n...
What is the current status of trial NCT01434303?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2012-01-10. Estimated completion is 2016-02-16.
What interventions are being tested in trial NCT01434303?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Entinostat (DRUG), Trastuzumab (BIOLOGICAL), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT01434303?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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