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A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer

NCT02370238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-09-16

Study results available
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Summary

The Objectives of this study:

The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone.

The secondary objectives were:

* To determine overall survival (OS).
* To evaluate objective response rates (ORR).
* To determine median PFS (mPFS).
* To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).

Conditions

Interventions

DRUG

paclitaxel

paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)

DRUG

Reparixin

reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle

DRUG

placebo

placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Lori J Goldstein, MD · FASCOFox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2019-02-20
Completion
2020-03-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Italy
  • Poland
  • Spain

Study Locations

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Entities

Drugs
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 NCT02370238 on ClinicalTrials.gov