MedTrace Logo

To Assess Efficacy and Safety of Oral Reparixin in Patients With Fatigue and Locally Advanced / Metastatic Breast Cancer

NCT05212701 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-04-30

No results posted yet for this study

Summary

Primary objective:

• To assess the efficacy of reparixin compared to placebo in limiting CRF in adult patients with locally advanced or metastatic breast cancer undergoing single-agent taxane chemotherapy, using FACITFatigue scale.

The secondary objectives are:

* To evaluate change in Quality of Life in the two treatment arms
* To assess the percentage of patients treated with reparixin compared to placebo delaying and discontinuing chemotherapy
* To assess Patient Global Impression of Severity (PGI-S) score and Patient Global Impression of Change (PGI-C) score associated with reparixin compared to placebo
* To assess the effect of reparixin compared to placebo on ECOG PS
* To assess the effects of reparixin vs placebo on Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS)

The safety objective is:

• To assess the safety and tolerability of reparixin in adult patients undergoing taxane-containing chemotherapy.

The pharmacokinetic (PK) objective is:

• To define the PK profile of orally administered reparixin, its metabolites (DF2243Y, DF2188Y, ibuprofen) and concomitant antineoplastic agents (paclitaxel, or nab-paclitaxel or docetaxel) in adult patients with locally advanced or metastatic breast cancer.

Conditions

Interventions

DRUG

Reparixin

The oral tablets of the investigational product (IP) will be administered with water prior to the start of the anticancer treatment infusion on Day 1 Cycle 1 and then administered approximately every eight hours (± 2 h) with a glass of water (about 250 mL) and a light meal or snack (it is preferable that reparixin is taken with food).

DRUG

Placebo

The oral tablets of masked placebo will be administered with water prior to the start of the anticancer treatment infusion on Day 1 Cycle 1 and then administered approximately every eight hours (± 2 h) with a glass of water (about 250 mL) and a light meal or snack

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Enrico Minnella, MD · Dompé Farmaceutici S.p.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-06-30
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy

Study Locations

More Related Trials

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 NCT05212701 on ClinicalTrials.gov