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NCT01516736 · ClinicalTrials.gov registry record · Phase 3
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
A Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
- 20
- Study locations
NCT01516736 is a Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia that has completed, run by Sandoz. The registered enrollment target is 308 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT01516736, a Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Conditions Studied
Interventions
- DRUG LA-EP2006
- DRUG Neulasta®
Study Locations (20)
Other
- Sandoz Investigational Site - San Miguel de Tucumán
- Sandoz Investigational Site - Temuco
- Sandoz Investigational Site - Chennai
- Sandoz Investigational Site - Delhi
- Sandoz Investigational Site - Gujarat
- Sandoz Investigational Site - Hyderabad
- Sandoz Investigational Site - Karamsad
- Sandoz Investigational Site - Lucknow
- Sandoz Investigational Site - Maharashtra
- Sandoz Investigational Site - Mangalore
Arkansas
- Sandoz Investigational Site - Hot Springs
- Sandoz Investigational Site - Jonesboro
California
- Sandoz Investigational Site - Corona
Kansas
- Sandoz Investigational Site - Wichita
Kentucky
- Sandoz Investigational Site - Mount Sterling
Michigan
- Sandoz Investigational Site - Detroit
North Dakota
- Sandoz Investigational Site - Bismarck
Oregon
- Sandoz Investigational Site - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01516736
The ClinicalTrials.gov registry entry for NCT01516736 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which LA-EP2006 is the first listed.
NCT01516736 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT01516736 about?
NCT01516736 is a clinical study titled "Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim". The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
What is the current status of trial NCT01516736?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2012-03. Estimated completion is 2013-12.
What conditions does trial NCT01516736 study?
This clinical trial studies the following conditions: Breast Cancer, Chemotherapy-induced Neutropenia.
What interventions are being tested in trial NCT01516736?
The interventions under investigation include: LA-EP2006 (DRUG), Neulasta® (DRUG).
Who is sponsoring clinical trial NCT01516736?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01516736 being conducted?
This trial has 20 study locations across Arkansas, California, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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