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

NCT02001974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-09-27

Study results available
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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

Interventions

DRUG

Paclitaxel+Reparixin

Association of Paclitaxel at fixed dosage with three increasing dosage of Reparixin

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Anne Schott, MD · University of Michigan

  • Lori Goldstein, MD · Fox Chase Cancer Center

  • Raymond Perez, MD · University of Kansas Medical Center

  • Tiffany Avery, MD · Thomas Jefferson University

  • Giraldo Kato, MD · Pinnacle Oncology Hematology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-27
Primary Completion
2014-06-25
Completion
2015-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001974 on ClinicalTrials.gov