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

Fatigue Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess Efficacy and Safety of Reparixin in Cancer Related Fatigue in Pts With Advanced / Metastatic Breast Cancer Undergoing Taxane-based Chemotherapy.

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled study. It will evenly randomize 68 evaluable men and women adult patients with CRF in locally advanced or metastatic breast cancer who are candidates to start single-agent taxane chemotherapy (paclitaxel, nab-paclitaxel or docetaxel). CRF will be assessed at baseline on a scale from 0 - 10 (with 10 being most severe), enrolling any patient who report a score of 1

• 6. Recruitment will be competitive among the study sites, until the planned number of patients is randomized. Patients will be assigned (1:1) to receive either oral reparixin treatment (1200 mg t.i.d. - treatment group) or masked placebo t.i.d. (control group). Randomization will be stratified by site and according to the type of chemotherapy (paclitaxel vs docetaxel vs nab-paclitaxel). Sparse blood samples will be collected in the whole population for reparixin (and metabolites), docetaxel, nab-paclitaxel, paclitaxel PK analysis. Reparixin or placebo will be administered for 16 weeks or until disease progression, withdrawal of consent or unacceptable toxicity, whichever occurs first. Following the completion of the treatment, or after premature discontinuation during the double-blind phase the patients will be followed up for safety assessments for an additional 30 days after last study therapy administration and will be followed for progressive disease and survival until twelve months after last enrolled subject off treatment, or until trial is terminated for other reasons, whatever occurs first.

Number of Patients Sixty-eight (68) evaluable adult patients with CRF with locally advanced or metastatic breast cancer who are candidates to receive single-agent taxane chemotherapy will be included in the study. Assuming that 10% of subjects will not be evaluable for primary analysis, a total of approximately 76 subjects is expected to be enrolled. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Fatigue
• Locally Advanced or Metastatic Breast Cancer

• NCT number: NCT05212701
• Study type: Interventional
• Source: Dompé Farmaceutici S.p.A
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 19, 2022
• Completion date: July 2024