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 JA (1,1), Iglesias M (2,2), Bohn U (3,3), Calvo E (4,4), Garcia Y (5,5), Guerra E (6,6), Manso L (7,7), Santaballa A (8,8), Gonzalez-Martin A (9,9).
(1) Department of Medical Oncology, Hospital Clinico Universitario de Valencia, CIBERONC, Spain.
(2) Department of Medical Oncology, Hospital Universitario Son Llatzer, Palma de Mallorca, Spain.
(3) Department of Medical Oncology, Hospital Universitario Dr Negrin, Las Palmas de Gran Canaria, Spain.
(4) Department of Medical Oncology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
(5) Department of Medical Oncology, Hospital Universitario Parc Tauli, Sabadell, Spain.
(6) Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
(7) Department of Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain.
(8) Department of Medical Oncology, Hospital Politecnico y Universitario La Fe, Valencia, Spain.
(9) Department of Medical Oncology, Clinica Universitaria de Navarra, Madrid, Spain.
Magazine: Future Science OA
Date: Jan 10, 2019Medical Oncology
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.
CITATION Future Sci OA. 2019 Jan 10;5(2):FSO370. doi: 10.4155/fsoa-2018-0107
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