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A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer
NC-6004 is a nanoparticle developed using micellar technology that can improve release of cisplatin, a standard treatment for many cancer types, and achieve selective distribution to tumors. Here, in the Phase II portion of this study, the activity, safety, tolerability, and effects on quality of li...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Impact Journals LLC
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443368/ https://www.ncbi.nlm.nih.gov/pubmed/32913555 http://dx.doi.org/10.18632/oncotarget.27684 |
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author | Volovat, Simona Ruxandra Ciuleanu, Tudor-Eliade Koralewski, Piotr Olson, Juneko E. Grilley Croitoru, Adina Koynov, Krassimir Stabile, Stefano Cerea, Giulio Osada, Atsushi Bobe, Iulian Volovat, Constantin |
author_facet | Volovat, Simona Ruxandra Ciuleanu, Tudor-Eliade Koralewski, Piotr Olson, Juneko E. Grilley Croitoru, Adina Koynov, Krassimir Stabile, Stefano Cerea, Giulio Osada, Atsushi Bobe, Iulian Volovat, Constantin |
author_sort | Volovat, Simona Ruxandra |
collection | PubMed |
description | NC-6004 is a nanoparticle developed using micellar technology that can improve release of cisplatin, a standard treatment for many cancer types, and achieve selective distribution to tumors. Here, in the Phase II portion of this study, the activity, safety, tolerability, and effects on quality of life of NC-6004 in combination with gemcitabine was examined in 34 squamous non-small cell lung carcinoma (NSCLC) patients, 50 biliary tract cancer patients, and 13 bladder cancer patients. All patients received 135 mg/m(2) NC-6004 on day one and 1,250 mg/m(2) gemcitabine on days one and eight. The median progression-free survival was 3.9 months in NSCLC patients, 4.3 months in biliary tract cancer patients, and 6.8 months in bladder cancer patients fit for cisplatin treatment. The most frequently reported Grade 3 Treatment Emergent Adverse Events across all cohorts were nausea, anemia and neutropenia, and hyponatremia. Quality of life measures for patients who received the combined therapy were generally consistent with expectations for patients undergoing chemotherapy. Overall, combined NC-6004 and gemcitabine treatment resulted in long-lasting antitumor activity and had a favorable safety profile, suggesting that it should be investigated further as a therapy for various types of cancer. |
format | Online Article Text |
id | pubmed-7443368 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Impact Journals LLC |
record_format | MEDLINE/PubMed |
spelling | pubmed-74433682020-09-09 A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer Volovat, Simona Ruxandra Ciuleanu, Tudor-Eliade Koralewski, Piotr Olson, Juneko E. Grilley Croitoru, Adina Koynov, Krassimir Stabile, Stefano Cerea, Giulio Osada, Atsushi Bobe, Iulian Volovat, Constantin Oncotarget Research Paper NC-6004 is a nanoparticle developed using micellar technology that can improve release of cisplatin, a standard treatment for many cancer types, and achieve selective distribution to tumors. Here, in the Phase II portion of this study, the activity, safety, tolerability, and effects on quality of life of NC-6004 in combination with gemcitabine was examined in 34 squamous non-small cell lung carcinoma (NSCLC) patients, 50 biliary tract cancer patients, and 13 bladder cancer patients. All patients received 135 mg/m(2) NC-6004 on day one and 1,250 mg/m(2) gemcitabine on days one and eight. The median progression-free survival was 3.9 months in NSCLC patients, 4.3 months in biliary tract cancer patients, and 6.8 months in bladder cancer patients fit for cisplatin treatment. The most frequently reported Grade 3 Treatment Emergent Adverse Events across all cohorts were nausea, anemia and neutropenia, and hyponatremia. Quality of life measures for patients who received the combined therapy were generally consistent with expectations for patients undergoing chemotherapy. Overall, combined NC-6004 and gemcitabine treatment resulted in long-lasting antitumor activity and had a favorable safety profile, suggesting that it should be investigated further as a therapy for various types of cancer. Impact Journals LLC 2020-08-18 /pmc/articles/PMC7443368/ /pubmed/32913555 http://dx.doi.org/10.18632/oncotarget.27684 Text en http://creativecommons.org/licenses/by/3.0/ Copyright: Volovat et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Paper Volovat, Simona Ruxandra Ciuleanu, Tudor-Eliade Koralewski, Piotr Olson, Juneko E. Grilley Croitoru, Adina Koynov, Krassimir Stabile, Stefano Cerea, Giulio Osada, Atsushi Bobe, Iulian Volovat, Constantin A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title | A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title_full | A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title_fullStr | A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title_full_unstemmed | A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title_short | A multicenter, single-arm, basket design, phase II study of NC-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
title_sort | multicenter, single-arm, basket design, phase ii study of nc-6004 plus gemcitabine in patients with advanced unresectable lung, biliary tract, or bladder cancer |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443368/ https://www.ncbi.nlm.nih.gov/pubmed/32913555 http://dx.doi.org/10.18632/oncotarget.27684 |
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