Ovarian Cancer Clinical Trials

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A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

Status: Recruiting
Location: See all (292) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.

• Participants must have platinum-resistant disease:

• Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum.

• Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.

• Participants must have radiologically progressed on or after their most recent line of therapy.

• Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment

• Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.

• Provision of an FFPE tumour tissue sample

Locations
United States
Alabama
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Birmingham
Arkansas
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Little Rock
California
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La Jolla
Washington, D.c.
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Washington D.c.
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Gainesville
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Jupiter
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Miami
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Weston
Illinois
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Chicago
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Evanston
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Peoria
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Urbana
Indiana
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Fort Wayne
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Indianapolis
Kentucky
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Louisville
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Burlington
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Worcester
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Towson
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Minneapolis
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Springfield
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Billings
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Chapel Hill
Nebraska
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Omaha
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Lebanon
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The Bronx
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Dayton
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Oregon
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Portland
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York
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Germantown
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San Antonio
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Tyler
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Virginia
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Fairfax
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Roanoke
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Australia
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Adelaide
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Garran
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Gosford
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Heidelberg
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Melbourne
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Richmond
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St Leonards
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Belgium
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Charleroi
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Edegem
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Ghent
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Leuven
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Libramont-chevigny
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Namur
Brazil
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Barretos
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Bela Vista
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Curitiba
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Goiânia
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Natal
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Porto Velho
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Kingston
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Montreal
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Québec
Chile
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Port Montt
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Providencia
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Santiago
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Santiago
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Santiago
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Santiago
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Santiago
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Santiago
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Viña Del Mar
China
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Beijing
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Beijing
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Beijing
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Chengdu
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Harbin
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Jinan
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Jinan
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Lanzhou
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Linyi
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Nanjing
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Nanjing
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Nanning
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Shanghai
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Shanghai
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Shenyang
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Shenyang
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Taiyuan
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Tianjin
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Wuhan
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Wuhan
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Wuhan
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Xi'an
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Zhanjiang
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Denmark
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Aalborg
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Aarhus
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Odense
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Vejle
France
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Amiens
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Avignon
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Nîmes
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Paris
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Pau
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Pierre-bénite
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Plerin Sur Mer
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Reims
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Saint-herblain
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Saint-priest-en-jarez
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Toulouse
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Tours
Germany
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Berlin
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Bonn
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Detmold
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Dresden
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Frankfurt Am Main
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Leipzig
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Tübingen
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Ulm
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Wiesbaden
Greece
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Athens
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Athens
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Athens
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Athens
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Kalamata
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Pátrai
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Rio
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Thessaloniki
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Bhubaneswar
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Chennai
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Delhi
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Dhanvantari Nagar
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Kolkata
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Nagpur
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Nashik
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Surat
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Tiruchirappalli
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Cork
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Israel
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Afula
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Beersheba
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Hadera
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Haifa
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Haifa
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Holon
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Jerusalem
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Kfar Saba
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Nahariya
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Ramat Gan
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Sofia
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Tel Aviv
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Catania
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Florence
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Naples
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Pisa
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Roma
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Roma
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Torino
Japan
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Chūōku
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Hidaka-shi
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Kashiwa
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Kobe
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Kōtoku
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Kurume-shi
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Nagoya
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Niigata
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Okayama
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Osaka
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Sagamihara-shi
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Sapporo
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Sendai
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Shinjuku-ku
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Shinjuku-ku
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Shiwa-gun
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Tsu
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Busan
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Daegu
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Seoul
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Seoul
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Suwon
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Yangsan
Spain
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Badalona
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Barcelona
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Córdoba
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Donostia / San Sebastian
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Girona
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L'hospitalet De Llobregat
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Madrid
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Madrid
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Valencia
Sweden
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Linköping
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Lund
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Solna
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Umeå
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Uppsala
Switzerland
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Basel
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Münsterlingen
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Sankt Gallen
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Thun
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Zollikerberg
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Zurich
Taiwan
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Changhua
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New Taipei City
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Taichung
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Taichung
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Tainan
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Tainan
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Taipei
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Taipei
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Taoyuan
Thailand
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Bangkok
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Bangkok
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Bangkok
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Chiang Mai
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Dusit
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Khon Kaen
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Songkhla
United Kingdom
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Barrow In Furness
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Birmingham
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Cambridge
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Canterbury
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Cardiff
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Edinburgh
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Greater London
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London
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London
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Nottingham
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Sutton
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Swansea
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2029-12-27
Participants
Target number of participants: 1100
Treatments
Experimental: AZD5335 in FRa-high cohort
AZD5335 IV (intravenous) in FRa-high cohort
Active_comparator: Mirvetuximab Soravtansine (MIRV) in FRa-high cohort
MIRV AIBW IV in FRa-high cohort
Experimental: AZD5335 in FRa-low cohort
AZD5335 IV (intravenous) in FRa-low cohort
Active_comparator: Investigator´s choice chemotherapy in FRa-low cohort
Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Ventana Medical Systems, Inc

This content was sourced from clinicaltrials.gov

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