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NCT02370238 · ClinicalTrials.gov registry record · Phase 2
A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT02370238 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 194 participants, roughly in line with the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target. The trial reports 20 study locations across 5 states.
The verdict
NCT02370238, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone. The secondary objectives were: * To determine overall survival (OS). * To evaluate objective response rates (ORR). * To determine median PFS (mPFS). * To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).
Conditions Studied
Interventions
- DRUG placebo
- DRUG paclitaxel
- DRUG Reparixin
Study Locations (20)
Georgia
- Atlanta Cancer Care - Alpharetta
- Northside Hospital, Inc.-Georgia Cancer Specialists - Athens
- Atlanta Cancer Care - Atlanta
- Northside Hospital, Inc. - Atlanta
- Northside Hospital, Inc.-Georgia Cancer Specialists - Canton
- Atlanta Cancer Care - Conyers
- Atlanta Cancer Care - Cumming
- Atlanta Cancer Care - Decatur
- Northside Hospital, Inc.-Georgia Cancer Specialists - Decatur
- Atlanta Cancer Care - Jonesboro
- Northside Hospital, Inc.-Georgia Cancer Specialists - Macon
- Northside Hospital, Inc.-Georgia Cancer Specialists - Marietta
- Southeastern Regional Medical Center - Newnan
- Northside Hospital, Inc.-Georgia Cancer Specialists - Sandy Springs
Florida
- Florida Cancer Specialists - Daytona Beach
- Florida Cancer Specialists - West Palm Beach
Illinois
- Swedish Covenant - Chicago
- Mid Illinois Hematology & Oncology Associates, Ltd. - Normal
Alabama
- Southern Cancer Center - Mobile
California
- CBCC Global Research a Comprehensive Blood and Cancer Center - Bakersfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2015-07-29 |
| Est. Completion | 2020-03-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02370238
The ClinicalTrials.gov registry entry for NCT02370238 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target. The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT02370238 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Georgia, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT02370238 about?
NCT02370238 is a clinical study titled "A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer". The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) crit...
What is the current status of trial NCT02370238?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2015-07-29. Estimated completion is 2020-03-23.
What conditions does trial NCT02370238 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT02370238?
The interventions under investigation include: placebo (DRUG), paclitaxel (DRUG), Reparixin (DRUG).
Who is sponsoring clinical trial NCT02370238?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02370238 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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