Ovarian Cancer Clinical Trial

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

Summary

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

View Full Description

Full Description

Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab.

The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer

Patients must be aged ≥18 years of age. For patients enrolled in Japan that are aged <20 year
All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
Mandatory provision of tumour sample for centralised tBRCA testing
ECOG performance status 0-1
Patients must have preserved organ and bone marrow function
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test

Key Exclusion Criteria:

Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology

Prior systemic anti-cancer therapy for ovarian cancer
Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation
Prior treatment with PARP inhibitor or immune mediated therapy
Planned intraperitoneal cytotoxic chemotherapy
Active or prior documented autoimmune or inflammatory disorders
Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
Clinically significant cardiovascular disease
Patients with known brain metastases

History of another primary malignancy except for:

Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy
Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination/comparator agents
Breast feeding women

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1407

Study ID:

NCT03737643

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 206 Locations for this study

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Foothill Ranch California, 92610, United States
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Los Angeles California, 90095, United States
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Orange California, 92868, United States
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San Francisco California, 94158, United States
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Tampa Florida, 33612, United States
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Augusta Georgia, 30912, United States
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Hinsdale Illinois, 60521, United States
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Indianapolis Indiana, 46202, United States
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Towson Maryland, 21204, United States
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Detroit Michigan, 48202, United States
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Springfield Missouri, 65807, United States
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Middletown New Jersey, 07748, United States
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Montvale New Jersey, 07645, United States
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Albany New York, 12208, United States
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New York New York, 10065, United States
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Uniondale New York, 11553, United States
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Durham North Carolina, 27710, United States
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Cleveland Ohio, 44195, United States
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Dayton Ohio, 45429, United States
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Hilliard Ohio, 43026, United States
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Tulsa Oklahoma, 74134, United States
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Lancaster Pennsylvania, 17601, United States
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Philadelphia Pennsylvania, 19104, United States
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Philadelphia Pennsylvania, 19107, United States
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Pittsburgh Pennsylvania, 15224, United States
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Salt Lake City Utah, 84112, United States
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Linz , 4020, Austria
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Wien , 1090, Austria
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Aalst , 9300, Belgium
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Leuven , 3000, Belgium
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Namur , 5000, Belgium
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Oostende , 8400, Belgium
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Sint-Niklaas , 9100, Belgium
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Barretos , 14784, Brazil
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Florianópolis , 88034, Brazil
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Fortaleza , 60810, Brazil
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Londrina , 86015, Brazil
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Porto Alegre , 90020, Brazil
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Porto Alegre , 90110, Brazil
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Rio de Janeiro , 20220, Brazil
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Sao Paulo , 01317, Brazil
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São Paulo , 04014, Brazil
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Burgas , 8000, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1330, Bulgaria
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Varna , 9000, Bulgaria
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Calgary Alberta, T2N 4, Canada
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Barrie Ontario, L4M 6, Canada
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Sudbury Ontario, P3E 5, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2X 3, Canada
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Montreal Quebec, H3T 1, Canada
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Montreal Quebec, H4A 3, Canada
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Rimouski Quebec, G5L 5, Canada
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Quebec , G1J 1, Canada
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Beijing , CN-10, China
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Beijing , , China
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Bengbu , 23306, China
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Changchun , 13002, China
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Changsha , 41000, China
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Changsha , 43003, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Dalian , 11600, China
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Guangzhou , 51006, China
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Guangzhou , 51008, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Harbin , 15008, China
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Hefei , 23003, China
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Jinhua , 32109, China
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Kunming , 65011, China
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Lanzhou , 73003, China
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Luzhou , 64609, China
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Nan Chong , 63700, China
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Nanjing , 21000, China
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Nanning , 53002, China
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Nantong , 22636, China
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Shanghai , 20001, China
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Shanghai , 20003, China
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Wuhan , 43003, China
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Wuhan , 43006, China
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Xi'an , 71006, China
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Zhengzhou , 45000, China
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Zhengzhou , 45000, China
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Zhuhai , 51909, China
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Aalborg , 9000, Denmark
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Aarhus N , 8200, Denmark
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Odense C , 5000, Denmark
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Roskilde , 4000, Denmark
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Vejle , 7100, Denmark
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Kuopio , 70210, Finland
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Oulu , 90029, Finland
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Turku , 20521, Finland
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Besançon , 25000, France
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Bordeaux , 33076, France
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Limoges Cedex , 87042, France
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Lyon Cedex 08 , 69373, France
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Marseille , 13273, France
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Nantes , 44202, France
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Paris Cedex 14 , 75674, France
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Paris , 75012, France
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Paris , 75015, France
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Saint Herblain Cedex , 44805, France
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Vandoeuvre les Nancy , 54519, France
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Bad Homburg , 61352, Germany
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Berlin , 10117, Germany
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Bielefeld , 33604, Germany
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Bonn , 53105, Germany
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Brandenburg , 14770, Germany
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Dresden , 1307, Germany
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Düsseldorf , 40489, Germany
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Essen , 45136, Germany
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Essen , 45147, Germany
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Esslingen am Neckar , 73730, Germany
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Frankfurt , 60590, Germany
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Freiburg , 79106, Germany
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Fürth , 90766, Germany
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Greifswald , 17475, Germany
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Gütersloh , 33332, Germany
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Hamburg , 20246, Germany
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Hamburg , 20357, Germany
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Hamburg , 22457, Germany
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Hannover , 30177, Germany
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Hannover , 30625, Germany
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Jena , 07747, Germany
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Karlsruhe , 76133, Germany
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Karlsruhe , 76135, Germany
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Kassel , 34125, Germany
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Kiel , 24105, Germany
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Köln , 50935, Germany
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Leipzig , 04103, Germany
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Ludwigsburg , 71640, Germany
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Lübeck , 23538, Germany
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Mainz , 55131, Germany
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Mannheim , 68167, Germany
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München , 81377, Germany
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Offenbach am Main , 63069, Germany
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Oldenburg , 26133, Germany
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Rosenheim , 83022, Germany
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Rostock , 18057, Germany
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Saalfeld , 07318, Germany
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Schweinfurt , 97422, Germany
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Tübingen , 72016, Germany
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Ulm , 89075, Germany
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Worms , 67550, Germany
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Budapest , 1062, Hungary
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Budapest , 1122, Hungary
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Debrecen , 4032, Hungary
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Győr , 9024, Hungary
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Kaposvár , 7400, Hungary
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Szeged , 6725, Hungary
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Zalaegerszeg , 8900, Hungary
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Brescia , 25123, Italy
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Lecce , 73100, Italy
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Lecco , 23900, Italy
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Milano , 20132, Italy
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Milano , 20141, Italy
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Mirano , 30035, Italy
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Napoli , 80131, Italy
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Reggio Calabria , 89100, Italy
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Reggio Emilia , 42100, Italy
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Roma , 00168, Italy
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Torino , 10126, Italy
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Torino , 10128, Italy
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Fukuoka-shi , 811-1, Japan
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Kashiwa-shi , 277-8, Japan
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Kobe-shi , 650-0, Japan
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Koto-ku , 135-8, Japan
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Kurume-shi , 830-0, Japan
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Kyoto-shi , 606-8, Japan
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Minato-ku , 105-8, Japan
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Nagoya-shi , 464-8, Japan
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Niigata-shi , 951-8, Japan
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Okayama-shi , 700-8, Japan
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Sapporo-shi , 003-0, Japan
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Sendai-shi , 980-8, Japan
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Shinjuku-ku , 160-8, Japan
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Sunto-gun , 411-8, Japan
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Toyoake-shi , 470-1, Japan
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Goyang-si , 10408, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Bellavista , CALLA, Peru
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La Libertad , 13013, Peru
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Lima , LIMA , Peru
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Lima , Lima , Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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San Isidro , 27, Peru
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Gdynia , 81-51, Poland
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Szczecin , 70-11, Poland
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Warszawa , 02-78, Poland
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Warszawa , 04-14, Poland
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Łódź , 93-51, Poland
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Floresti , 40728, Romania
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Córdoba , 14004, Spain
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Madrid , 28033, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Terrassa(Barcelona) , 08221, Spain
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Vigo , 36312, Spain
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Adana , 1260, Turkey
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Ankara , 06230, Turkey
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Ankara , 06490, Turkey
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Istanbul , 34093, Turkey
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Istanbul , 34384, Turkey
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Izmir , 35100, Turkey

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1407

Study ID:

NCT03737643

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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