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NCT05212701
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.
Phase 2 trial testing Reparixin in Fatigue. Withdrawn.
1 June 2023
Quick facts
| Lead sponsor | Dompé Farmaceutici S.p.A |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 19 April 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 July 2024 |
| Sites | 20 locations across United States, Germany, Italy |
Drugs / interventions tested
- Reparixin — full drug profile →
- Placebo
Conditions studied
- Fatigue — all drugs for Fatigue →
- Locally Advanced or Metastatic Breast Cancer — all drugs for Locally Advanced or Metastatic Breast Cancer →
Sponsor
Dompé Farmaceutici S.p.A — full company profile →
Who can join
18 and older, any sex, with Fatigue or Locally Advanced or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Change from baseline in FACIT-F score
Time frame: week 16
The Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue) scale is a 13-item instrument designed to assess fatigue/ tiredness and its impact on daily activities and functioning in a number of chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (e.g., sleeping, and socia
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6 -
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
Therapeutic inhibition of CXCR1/2: where do we stand?
Sitaru S, Budke A, Bertini R, Sperandio M. · · 2023 · cited 40× · PMID 37249756 · DOI 10.1007/s11739-023-03309-5 -
Multifaceted Roles of Chemokine C-X-C Motif Ligand 7 in Inflammatory Diseases and Cancer.
Wu Q, Tu H, Li J. · · 2022 · cited 25× · PMID 35837284 · DOI 10.3389/fphar.2022.914730 -
The role of extracellular vesicles and interleukin-8 in regulating and mediating neutrophil-dependent cancer drug resistance.
Zippoli M, Ruocco A, Novelli R, Rocchio F, et al · · 2022 · cited 6× · PMID 36591453 · DOI 10.3389/fonc.2022.947183 -
The soldiers needed to be awakened: Tumor-infiltrating immune cells.
Yaping W, Zhe W, Zhuling C, Ruolei L, et al · · 2022 · cited 5× · PMID 36246629 · DOI 10.3389/fgene.2022.988703 -
Cytokine Landscape in Central Nervous System Metastases.
Marin J, Journe F, Ghanem GE, Awada A, et al · · 2022 · cited 4× · PMID 35884845 · DOI 10.3390/biomedicines10071537
Verify or expand the search:
- PubMed search for NCT05212701
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Reparixin
Trials testing the same drug.
- NCT05254990 — Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia · Phase 3 · terminated
- NCT04878055 — Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia. · Phase 3 · completed
- NCT04794803 — Reparixin in COVID-19 Pneumonia - Efficacy and Safety · Phase 2, PHASE3 · terminated
- NCT02370238 — A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer · Phase 2 · completed
- NCT03031470 — Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation · Phase 2 · terminated
Other recruiting trials for Fatigue
Currently open trials in the same condition.
- NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
- NCT07421960 — Investigation of the Relationship Between Periodontitis and Sleep Quality · recruiting
- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07386691 — Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodi · NA · active not recruiting
- NCT06819254 — Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors · Phase 4 · recruiting
Other Dompé Farmaceutici S.p.A trials
Trials by the same sponsor.
- NCT06411132 — Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye · terminated
- NCT06411145 — Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis · Phase 4 · withdrawn
- NCT06244316 — A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Comp · Phase 2 · completed
- NCT05552261 — DEFENDO Long Term Follow-up Study in Stage 1 NK Patients · completed
- NCT05496868 — Add-on Reparixin in Adult Patients With ARDS · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05212701 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dompé Farmaceutici S.p.A
- Last refreshed: 29 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05212701.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing