Clinical trialNCT02001974CompletedPhase 1Interventional

Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)

SponsorDompé Farmaceutici S.p.AEnrollment33Metastatic Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anne Schott, MD
University of Michigan
Principal Investigator
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Giraldo Kato, MD
Pinnacle Oncology Hematology
Principal Investigator
clinicaltrials.gov ↗
Lori Goldstein, MD
Fox Chase Cancer Center
Principal Investigator
clinicaltrials.gov ↗
Raymond Perez, MD
University of Kansas Medical Center
Principal Investigator
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Tiffany Avery, MD
Thomas Jefferson University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Pinnacle Oncology Hematology; 9055 East del Camino
Scottsdale, Arizona, United States
University of Kansas Medical Center; 4350 Shawnee Mission Parkway
Fairway, Kansas, United States
University of Michigan; 1500 East Medical Center Drive
Ann Arbor, Michigan, United States
Fox Chase Cancer Center; 333 Cottman Avenue
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital; 1025 Walnut Street
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Paclitaxel+Reparixin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 Feb 2012
Primary completion: 25 Jun 2014
Completion: 15 Jan 2015
Last update posted: 27 Sept 2021
Registered enrollment: 33
Registry id: NCT02001974

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.