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GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer

Response to polyadenosine diphosphate ribose polymerase (PARP) inhibitors in platinum-resistant ovarian cancer and in the absence of BRCA mutations is very low. Combining PARP inhibitors with other agents might overcome this lack of activity. Here we describe the rationale and design of GEICO1601-RO...

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Autores principales: Perez-Fidalgo, J Alejandro, Iglesias, Maria, Bohn, Uriel, Calvo, Elisa, Garcia, Yolanda, Guerra, Eva, Manso, Luis, Santaballa, Ana, Gonzalez-Martin, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Science Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391624/
https://www.ncbi.nlm.nih.gov/pubmed/30820349
http://dx.doi.org/10.4155/fsoa-2018-0107
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author Perez-Fidalgo, J Alejandro
Iglesias, Maria
Bohn, Uriel
Calvo, Elisa
Garcia, Yolanda
Guerra, Eva
Manso, Luis
Santaballa, Ana
Gonzalez-Martin, Antonio
author_facet Perez-Fidalgo, J Alejandro
Iglesias, Maria
Bohn, Uriel
Calvo, Elisa
Garcia, Yolanda
Guerra, Eva
Manso, Luis
Santaballa, Ana
Gonzalez-Martin, Antonio
author_sort Perez-Fidalgo, J Alejandro
collection PubMed
description Response to polyadenosine diphosphate ribose polymerase (PARP) inhibitors in platinum-resistant ovarian cancer and in the absence of BRCA mutations is very low. Combining PARP inhibitors with other agents might overcome this lack of activity. Here we describe the rationale and design of GEICO1601-ROLANDO (resistant ovarian cancer treated with olaparib and pegylated liposomal doxorubin; NCT03161132). ROLANDO is a Phase II single-arm multicenter trial in which patients are treated with a combination of olaparib and pegylated liposomal doxorubicin (PLD) in platinum-resistant epithelial ovarian, primary peritoneal, or Fallopian tube cancer regardless of the BRCA mutation status. The primary end point is progression-free survival at 6 months. Other secondary end points are response rate, disease control rate, quality of life and overall survival.
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spelling pubmed-63916242019-02-28 GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer Perez-Fidalgo, J Alejandro Iglesias, Maria Bohn, Uriel Calvo, Elisa Garcia, Yolanda Guerra, Eva Manso, Luis Santaballa, Ana Gonzalez-Martin, Antonio Future Sci OA Clinical Trial Protocol Response to polyadenosine diphosphate ribose polymerase (PARP) inhibitors in platinum-resistant ovarian cancer and in the absence of BRCA mutations is very low. Combining PARP inhibitors with other agents might overcome this lack of activity. Here we describe the rationale and design of GEICO1601-ROLANDO (resistant ovarian cancer treated with olaparib and pegylated liposomal doxorubin; NCT03161132). ROLANDO is a Phase II single-arm multicenter trial in which patients are treated with a combination of olaparib and pegylated liposomal doxorubicin (PLD) in platinum-resistant epithelial ovarian, primary peritoneal, or Fallopian tube cancer regardless of the BRCA mutation status. The primary end point is progression-free survival at 6 months. Other secondary end points are response rate, disease control rate, quality of life and overall survival. Future Science Ltd 2019-01-10 /pmc/articles/PMC6391624/ /pubmed/30820349 http://dx.doi.org/10.4155/fsoa-2018-0107 Text en © 2019 J. Alejandro Perez-Fidalgo This work is licensed under a Creative Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/)
spellingShingle Clinical Trial Protocol
Perez-Fidalgo, J Alejandro
Iglesias, Maria
Bohn, Uriel
Calvo, Elisa
Garcia, Yolanda
Guerra, Eva
Manso, Luis
Santaballa, Ana
Gonzalez-Martin, Antonio
GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title_full GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title_fullStr GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title_full_unstemmed GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title_short GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
title_sort geico1601-rolando: a multicentric single arm phase ii clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
topic Clinical Trial Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391624/
https://www.ncbi.nlm.nih.gov/pubmed/30820349
http://dx.doi.org/10.4155/fsoa-2018-0107
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