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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: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by Dompé Farmaceutici S.p.A.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS was defined as the number of days between the date of randomization and the date of clinical disease progression, according to RECIST criteria version 1.1, as assessed by Independent Radiology Review, or to death due to any cause, whichever occurred first. Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.
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 |
What the finished NCT02370238 record still lists
NCT02370238 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target.
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT02370238's enrollment target sits among peer trials
194 32nd of 139 higher than 107 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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