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NCT02001974 · ClinicalTrials.gov registry record · Phase 1
Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)
A Phase 1 study of Metastatic Breast Cancer, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 5
- Study locations
NCT02001974: Completed Phase 1 study of Metastatic Breast Cancer, sponsored by Dompé Farmaceutici S.p.A.
NCT02001974 is a Phase 1 study of Metastatic Breast Cancer that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 33 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02001974, a Phase 1 study of Metastatic Breast Cancer, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth factor receptor-2) negative metastatic breast cancer patients. The primary objective of this study was to evaluate the safety and define the pharmacokinetic (PK) profile of orally administered reparixin in combination with paclitaxel in HER-2 negative MBC patients. The secondary objectives were to: 1. Evaluate the effects of orally administered reparixin on cancer stem cell (CSC) markers, the tumoral microenvironment and markers of cytokine inflammation; 2. Evaluate peripheral blood samples for enumeration of circulating tumor cells (CTCs), molecular characterization as CSCs and perform epithelial-mesenchymal transition (EMT) biomarker profiling; 3. Assess disease response for indication of efficacy.
Primary Outcome
Monitoring of AEs throughout the study till the end/off-treatment visit.
Conditions Studied
Interventions
- DRUG Paclitaxel+Reparixin
Study Locations (5)
Pennsylvania
- Thomas Jefferson University Hospital; 1025 Walnut Street - Philadelphia
- Fox Chase Cancer Center; 333 Cottman Avenue - Philadelphia
Arizona
- Pinnacle Oncology Hematology; 9055 East Del Camino - Scottsdale
Kansas
- University of Kansas Medical Center; 4350 Shawnee Mission Parkway - Fairway
Michigan
- University of Michigan; 1500 East Medical Center Drive - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2015-01-15 |
| Phase | Phase 1 |
What the finished NCT02001974 record still lists
NCT02001974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Paclitaxel+Reparixin is the first listed.
NCT02001974 lists 5 locations in 4 states (Pennsylvania, Arizona, Kansas).
Frequently Asked Questions
What is clinical trial NCT02001974 about?
NCT02001974 is a clinical study titled "Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)". This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth factor receptor-2) negative metastatic breast cancer patients. The primary objective of this study was to evalu...
What is the current status of trial NCT02001974?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-02-27. Estimated completion is 2015-01-15.
What conditions does trial NCT02001974 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT02001974?
The interventions under investigation include: Paclitaxel+Reparixin (DRUG).
Who is sponsoring clinical trial NCT02001974?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02001974 being conducted?
This trial has 5 study locations across Arizona, Kansas, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02001974's enrollment target sits among peer trials
33 102nd of 139 higher than 37 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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