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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 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.

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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.

Conditions Studied

Metastatic Breast Cancer

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

FieldValue
Enrollment Target 33 participants
Start Date 2012-02-27
Est. Completion 2015-01-15
Phase Phase 1

Sponsor

Dompé Farmaceutici S.p.A

27 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02001974

The ClinicalTrials.gov registry entry for NCT02001974 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (84% lower). 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 1 intervention - of which Paclitaxel+Reparixin is the first listed.

NCT02001974 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.