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COMPLETED Phase 1

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

NCT02001974 · View on ClinicalTrials.gov ↗

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

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

9 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02001974 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Pennsylvania, Arizona, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02001974?

The interventions under investigation include: Paclitaxel+Reparixin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02001974?

This trial is sponsored by Dompé Farmaceutici S.p.A, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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