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Review
. 2019 Jan 10;5(2):FSO370.
doi: 10.4155/fsoa-2018-0107. eCollection 2019 Feb.

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

J Alejandro Perez-Fidalgo  1   1 , Maria Iglesias  2   2 , Uriel Bohn  3   3 , Elisa Calvo  4   4 , Yolanda Garcia  5   5 , Eva Guerra  6   6 , Luis Manso  7   7 , Ana Santaballa  8   8 , Antonio Gonzalez-Martin  9   9
Affiliations
Review

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

J Alejandro Perez-Fidalgo et al. Future Sci OA. .

Abstract

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.

Keywords: maintenance; olaparib; ovarian cancer; pegylated liposomal doxorubicin; platinum-resistant.

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Conflict of interest statement

Financial & competing interests disclosure This trial received financial support from AstraZeneca. JA Perez-Fidalgo discloses lectures, advisories or traveling support from AstraZeneca, Roche, Pharmamar, Clovis and Pfizer. E Guerra discloses a role as advisory board for AstraZeneca. L Manso discloses lectures, advisories/consultant role and research funding from Tesaro, AstraZeneca, Roche, Novartis and Celgene. A Gonzalez-Martin discloses lectures, advisories or traveling support from AstraZeneca, Roche, Tesaro, Clovis, Pfizer-Merck and Pharmamar. The rest of the authors have no disclosures to declare. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Treatment schedule of the GEICO1601-ROLANDO trial.
b.i.d.: Twice daily.
See this image and copyright information in PMC

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