Spots Global Cancer Trial Database for Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
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Trial Identification
Brief Title: Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
Official Title: Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.
Study ID: NCT03161132
Conditions
Study Description
Brief Summary: Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.
Detailed Description: The combination of Poly (ADP-ribose) polymerase (PARP) inhibitors with PLD may provide a synergistic effect in patients with advanced ovarian cancer, especially those with Homologous recombination deficiency (HRD), because of the decreased ability to repair chemotherapy-induced DNA damage. Preclinical studies with PARP inhibitors have shown potentiation of the cytotoxic effects of chemotherapeutic agents and a recent phase I study has shown the tolerability of the combination and efficacy in recurrent ovarian cancer. In this study, encouraging efficacy results were seen in ovarian cancer patients and were not limited by Germline BRCA1/2 (gBRCA) Mutations status or sensitivity to platinum therapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Corporación Sanitaria Parc Taulí, Sabadell, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín, Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Son Llatzer, Palma De Mallorca, Mallorca, Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario y Politécnico La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Alejandro Pérez-Fidalgo, M.D., Ph.D.
Affiliation: University of Valencia, Hospital Clinico Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
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