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NCT01861054 · ClinicalTrials.gov registry record · Phase 2
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01861054 is a Phase 2 study that was terminated before completion, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 20 participants.
The verdict
NCT01861054, a Phase 2 study, was terminated before completion, sponsored by Dompé Farmaceutici S.p.A.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery. The primary objectives of this study were: 1- to evaluate the effects of orally administered reparixin on CSCs in the primary tumor and the tumoral microenvironment in an early breast cancer population: A. CSC were measured in tissue samples by techniques that could include: ALDEFLUOR assay and assessment of CD44/CD24 by flow cytometry, or examination of RNA transcripts by RT-PCR, aldehyde dehydrogenase-1, CD44/CD24 and epithelial mesenchymal transition markers (Snail, Twist, Notch) by immunohistochemistry (IHC). CSC were defined as ALDEFLUOR positive (ALDH-1+) and/or CD44 high/CD24 low by flow cytometry or RT-PCR and IHC and by the detection of ALDH-1+ cells with or without epithelial mesenchymal transition (EMT) transcription factor in IHC assays. B. Serine-threonine protein kinase (AKT), focal adhesion kinase (FAK), phosphatase and tensin homolog (PTEN) and chemokine receptor-1 (CXCR1) levels were measured in tissue samples by IHC. C. Measurement of markers of inflammation (interleukin-1beta \[IL-1β\], interleukin-6 \[IL-6\], interleukin-8 \[IL-8\], tumor necrosis factor-alpha \[TNF-α\], granulocyte macrophage colony stimulating factor \[GM-CSF\], vascular endothelial growth factor \[VEGF\], basic fibroblast growth factor \[b-FGF\] and high-sensitivity C-reactive protein \[hsCRP\]) in plasma, leukocyte subsets (enumerate T subsets, B, and natural killer/natural killer T \[NK/NKT\] cells) and study polymorphonuclear leukocyte \[PMN\] biology in peripheral blood samples. D. Measurement of markers of angiogenesis (CD31 staining), tumor-infiltrating leukocytes (CD4, CD8, NK and macrophages), autophagy (P62 and LC3 by IHC), EpCAM and EMT markers (CD326, CD45, Twist1, SNAIL1, SLUG, ZEB1, FOXC2, TG2, Akt2, P13k and CK19 by RT-PCR) and tissue cellularity (residual dise
Interventions
- DRUG Reparixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01861054
The ClinicalTrials.gov registry entry for NCT01861054 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Reparixin is the first listed.
NCT01861054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01861054 about?
NCT01861054 is a clinical study titled "Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer". This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery. The primary objectives of this study were: 1- to evaluate the effects of orally administered repa...
What is the current status of trial NCT01861054?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-02. Estimated completion is 2016-03-01.
What interventions are being tested in trial NCT01861054?
The interventions under investigation include: Reparixin (DRUG).
Who is sponsoring clinical trial NCT01861054?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
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