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D9319C00001- 1L OC Mono Global RCT
Sponsor: AstraZeneca
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
366
Start Date
2021-05-31
Completion Date
2027-07-27
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Olaparib
Olaparib tablets 300 mg oral twice daily
Matching placebo
Matching placebo tablets taken orally at a dose of 300 mg twice daily
Locations (89)
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Santiago, Chile
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Santiago, Chile
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Temuco, Chile
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Temuco, Chile
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Viña del Mar, Chile
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Baoji, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Guiyang, China
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Haikou, China
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Hangzhou, China
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Hefei, China
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Hefei, China
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Jiaxing, China
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Jining, China
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Lanzhou, China
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Linyi, China
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Nanjing, China
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Qingdao, China
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Rui’an, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Tianjin, China
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Tianjin, China
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Ürümqi, China
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Ürümqi, China
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Wenzhou, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Wuxi, China
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Xuzhou, China
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Xuzhou, China
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Yanji, China
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Zibo, China
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Zunyi, China
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Bogotá, Colombia
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Bogotá, Colombia
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Medellín, Colombia
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Gūrgaon, India
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Jaipur, India
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Kolkata, India
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Madurai, India
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Namakkal, India
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Nashik, India
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New Delhi, India
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New Delhi, India
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Arequipa, Peru
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Lima, Peru
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Lima, Peru
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Lima, Peru
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San Isidro, Peru
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Moscow, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Yekaterinburg, Russia
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Port Elizabeth, South Africa
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Cordaleo, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Chernihiv, Ukraine
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kryvyi Rih, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Zaporizhzhia, Ukraine
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam