Reparixin for Fatigue

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fatigue+2 More
Reparixin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is assessing whether the drug reparixin can help limit cancer-related fatigue (CRF) in adult patients with breast cancer who are undergoing taxane chemotherapy. The secondary objectives are to evaluate quality of life, percentage of patients who delay or discontinue chemotherapy, and other measures. The safety objective is to assess the safety and tolerability of reparixin in these patients. The pharmacokinetic objective is to define the PK profile of orally administered reparixin and its metabolites.

Eligible Conditions
  • Fatigue
  • Breast

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fatigue

Study Objectives

0 Primary · 10 Secondary · Reporting Duration: Up to 12 months post-treatment

Week 70
Overall Response Rate (ORR)
Month 12
Overall Survival (OS)
Month 12
Progression Free Survival (PFS)
Week 70
Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Week 70
Patient Global Impression of Change (PGI-C) score
Week 70
Patient Global Impression of Severity (PGI-S) score
Week 70
EQ-5D-5L score
Week 70
Proportion of patients delaying next administration of chemotherapy due to CRF
Proportion of patients discontinuing chemotherapy due to CRF
Week 4
Change from baseline in FACIT-F score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Fatigue

Side Effects for

Reparixin Group
45%Nausea
28%Headache
24%Diarrhoea
24%Vomiting
24%Abdominal pain
21%Hypoglycaemia
21%Anaemia
14%Malaise
10%Blood creatinine increased
10%Pyrexia
10%Constipation
10%Hypertension
10%Catheter site pain
10%Procedural pain
10%Musculoskeletal pain
10%Hyperkalaemia
7%Epistaxis
7%Intra-abdominal haemmorrhage
7%Tachycardia
7%Peritoneal haemorrhage
7%Nasal congestion
7%Hypotension
7%Stomatitis
7%Back pain
7%Portal vein presssure increased
7%Pruritus
7%Alloimmunisation
3%Peripheral swelling
3%HLA marker study positive
3%Implant site haemorrhage
3%Acute psychosis
3%Hepatic haemorrhage
3%Anxiety
3%Multiple organ dysfunction syndrome
3%Transplant rejection
3%Angina pectoris
3%Upper limb fracture
3%Arthralgia
3%Oedema peripheral
3%Cervical vertebral fracture
3%Sepsis
3%Bradycardia
3%Generalised oedema
3%Complications of transplant surgery
3%Fluid retention
3%C-reactive protein increased
3%Tremor
3%Pain in extremity
3%Abdominal pain upper
3%Neutropenia
3%Chest discomfort
3%Diabetic neuropathy
3%Hypoglycemia
3%Coccidioidomycosis
3%Adenocarcinoma
3%Fall
3%Hyperhidrosis
3%Urinary tract infection
3%Incision site pain
3%Migrane
3%Dysgeusia
3%Rhinorrhoea
3%Hot flush
3%Acne
3%Erythema
3%Lip swelling
3%Head injury
3%joint swelling
3%Aspartate aminotransferase increased
3%Fatigue
3%Decreased appetite
3%Upper-airway cough syndrome
3%Syncope
3%Insomnia
3%Leukopenia
3%Generalised tonic-clonic seizure
3%Hepatic enzyme increased
3%Haemorrhage
3%Catheter site haemorrhage
3%Lip oedema
3%Chills
3%Neck pain
3%Vessel puncture site erythema
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01817959) in the Reparixin Group ARM group. Side effects include: Nausea with 45%, Headache with 28%, Diarrhoea with 24%, Vomiting with 24%, Abdominal pain with 24%.

Trial Design

2 Treatment Groups

Reparixin
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

76 Total Participants · 2 Treatment Groups

Primary Treatment: Reparixin · Has Placebo Group · Phase 2

Reparixin
Drug
Experimental Group · 1 Intervention: Reparixin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reparixin
2012
Completed Phase 3
~710

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months post-treatment

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
45 Previous Clinical Trials
4,195 Total Patients Enrolled
Enrico Maria Minnella, MDStudy DirectorDompé farmaceutici SpA

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, and are at least 18 years of age.
CRF score > 6 on a NRS from 0 to 10, lasting for a minimum of 4 days, during the previous 24 hours and lasting for a minimum of 4 days.
You are able to swallow and retain oral medication (intact tablet).
You have a serum creatinine level of < 140 μmol/L (< 1.
You have provided written informed consent before the initiation of any study-specific procedures.\n
Pathologically documented locally advanced (not amenable to surgical resection) or metastatic HER2-negative breast cancer.
You have a low blood hemoglobin level, a low absolute neutrophil count, and a low platelet count.
You have a serum bilirubin level that is within the normal range.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.