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Chemokine Receptor Antagonist

Reparixin for Fatigue

Phase 2

Waitlist Available

Research Sponsored by Dompé Farmaceutici S.p.A

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-treatment

Awards & highlights

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 Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change from baseline in FACIT-F score

Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

EQ-5D-5L score

+7 more

Side effects data

From 2017 Phase 3 trial • 51 Patients • NCT01817959

45%

Nausea

28%

Headache

24%

Vomiting

24%

Abdominal pain

24%

Diarrhoea

21%

Hypoglycaemia

21%

Anaemia

14%

Malaise

10%

Blood creatinine increased

10%

Catheter site pain

10%

Procedural pain

10%

Hyperkalaemia

10%

Musculoskeletal pain

10%

Constipation

10%

Hypertension

10%

Pyrexia

Epistaxis

Nasal congestion

Intra-abdominal haemmorrhage

Peritoneal haemorrhage

Stomatitis

Portal vein presssure increased

Back pain

Alloimmunisation

Pruritus

Hypotension

Tachycardia

Aspartate aminotransferase increased

Insomnia

Multiple organ dysfunction syndrome

Rhinorrhoea

Urinary tract infection

Generalised oedema

Acute psychosis

Haemorrhage

Lip swelling

Catheter site haemorrhage

Chest discomfort

Chills

Fatigue

Vessel puncture site erythema

Hepatic haemorrhage

Coccidioidomycosis

Fall

Head injury

Incision site pain

C-reactive protein increased

Decreased appetite

Fluid retention

Arthralgia

joint swelling

Neck pain

Pain in extremity

Dysgeusia

Migrane

Implant site haemorrhage

Oedema peripheral

Lip oedema

Acne

Leukopenia

Neutropenia

Abdominal pain upper

Erythema

Hyperhidrosis

Hot flush

Transplant rejection

Sepsis

Cervical vertebral fracture

Complications of transplant surgery

Upper limb fracture

HLA marker study positive

Hepatic enzyme increased

Hypoglycemia

Adenocarcinoma

Diabetic neuropathy

Generalised tonic-clonic seizure

Angina pectoris

Bradycardia

Peripheral swelling

Syncope

Tremor

Anxiety

Upper-airway cough syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Reparixin Group

Placebo Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ReparixinExperimental Treatment1 Intervention

Reparixin will be administered orally at the dose of 1200 mg (2 x 600 mg tablets) three times daily (total dose of 3600 mg/day) with no interruptions during each cycle.

Group II: PlaceboPlacebo Group1 Intervention

Masked placebo will be administered orally (2 tablets) three times daily with no interruptions during each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reparixin

2012

Completed Phase 3

~710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor

49 Previous Clinical Trials

4,534 Total Patients Enrolled

Enrico Maria Minnella, MDStudy DirectorDompé farmaceutici SpA

1 Previous Clinical Trials

526 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are medical centers participating in this trial?

"This clinical trial is currently occurring at five medical centres, including those in Fort Myers, Minneapolis and Cary. Choosing the one nearest to you will help limit the amount of travel necessary for participation."

Answered by AI

Are people presently being accepted for this clinical investigation?

"Affirmative. Per the information on clinicaltrials.gov, this research endeavor is actively recruiting trial participants since its posting on April 19th 2022 and most recent update occurring in May 17th 2022. 76 patients need to be recruited from 5 distinct medical centres for the study to proceed."

Answered by AI

Has Reparixin been authorized by the Food and Drug Administration?

"Due to the preliminary nature of Reparixin, being a Phase 2 trial with data supporting safety but not efficacy, Power rated its safety at 2."

Answered by AI

What is the uppermost limit of participants in this experiment?

"This clinical trial necessitates the participation of 76 qualified individuals. Patients can partake in this evaluation from a variety of venues, such as Florida Cancer Specialists and Research Institute LLC in Fort Myers, or University of Minnesota Medical Center, Fairview situated in Minneapolis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "To Assess Efficacy and Safety of Oral Reparixin in Patients With Fatigue and Locally Advanced / Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05212701.