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Brief Title: D9319C00001- 1L OC Mono Global RCT
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants With BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)
Study ID: NCT04884360
Brief Summary: This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Temuco, , Chile
Research Site, Viña del Mar, , Chile
Research Site, Baoji, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guiyang, , China
Research Site, Haikou, , China
Research Site, Haikou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Jiaxing, , China
Research Site, Jinan, , China
Research Site, Jining, , China
Research Site, Lanzhou, , China
Research Site, Lanzhou, , China
Research Site, Linyi, , China
Research Site, Nanjing, , China
Research Site, Qingdao, , China
Research Site, Qingdao, , China
Research Site, Rui'an, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shengyang, , China
Research Site, Shenyang, , China
Research Site, Shijiazhuang, , China
Research Site, Suzhou, , China
Research Site, Tianjin, , China
Research Site, Tianjin, , China
Research Site, Urumqi, , China
Research Site, Urumqi, , China
Research Site, Wenzhou, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Wuxi, , China
Research Site, Xi'an, , China
Research Site, Xiamen, , China
Research Site, Xianyang, , China
Research Site, Xuzhou, , China
Research Site, Xuzhou, , China
Research Site, Yanji, , China
Research Site, Zibo, , China
Research Site, Zunyi, , China
Research Site, Barranquilla, , Colombia
Research Site, Bogota D.C., , Colombia
Research Site, Bogota, , Colombia
Research Site, Bogotá, , Colombia
Research Site, Bogotá, , Colombia
Research Site, Ibague, , Colombia
Research Site, Medellin, , Colombia
Research Site, Medellín, , Colombia
Research Site, Gurgaon, , India
Research Site, Jaipur, , India
Research Site, Kolkata, , India
Research Site, Kolkata, , India
Research Site, Madurai, , India
Research Site, Namakkal, , India
Research Site, Nashik, , India
Research Site, New Delhi, , India
Research Site, New Delhi, , India
Research Site, Arequipa, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, San Isidro, , Peru
Research Site, Cebu, , Philippines
Research Site, Quezon City, , Philippines
Research Site, West San Juan City, , Philippines
Research Site, Gdynia, , Poland
Research Site, Gliwice, , Poland
Research Site, Grzepnica, , Poland
Research Site, Poznań, , Poland
Research Site, Szczecin, , Poland
Research Site, Arkhangelsk, , Russian Federation
Research Site, Chelyabinsk, , Russian Federation
Research Site, Ekaterinburg, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Nizhniy Novgorod, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Sankt-Peterburg, , Russian Federation
Research Site, St Petersburg, , Russian Federation
Research Site, Tomsk, , Russian Federation
Research Site, Cape Town, , South Africa
Research Site, Johannesburg, , South Africa
Research Site, Parktown, , South Africa
Research Site, Port Elizabeth, , South Africa
Research Site, Rondebosch, , South Africa
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Karsiyaka, , Turkey
Research Site, Samsun, , Turkey
Research Site, Chernihiv, , Ukraine
Research Site, Dnipro, , Ukraine
Research Site, Ivano-Frankivsk, , Ukraine
Research Site, Kharkiv, , Ukraine
Research Site, Kryvyi Rih, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Zaporizhzhia, , Ukraine
Research Site, Ha noi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Name: Xiaohua Wu
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR