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ACTIVE NOT RECRUITING
NCT04884360
PHASE3

D9319C00001- 1L OC Mono Global RCT

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

DRUG

Olaparib

Olaparib tablets 300 mg oral twice daily

OTHER

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