Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
NCT ID: NCT04729387
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
358 participants
INTERVENTIONAL
2021-07-22
2025-12-05
Brief Summary
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Detailed Description
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Participants will continue to receive study treatment until disease progression, unacceptable toxicity that precludes further treatment, or until discontinuation of study treatment due to any other reason. After treatment discontinuation, all participants will enter in the post-treatment follow-up period, which consists of a safety follow-up visit and a 9-week post-progression visit. Once they complete the post-treatment follow-up, participants will then enter the survival follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alpelisib+olaparib
Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule.
Alpelisib
Alpelisib will be administered at 200 mg orally once daily following food on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle
Olaparib
Olaparib will be administered at 200 mg orally twice daily irrespective of meals on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.
Paclitaxel or PLD
Investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel 80 mg/m2 intravenously weekly or Pegylated liposomal Doxorubicin (PLD) 40-50 mg/m2 (physician discretion) intravenously every 28 days.
Paclitaxel
Paclitaxel will be administered at 80 mg/m2 as an intravenous infusion weekly during a 28-day treatment cycle, starting on Cycle 1 Day 1, and on Day 8, Day 15 and Day 22 of every cycle thereafter
Pegylated liposomal doxorubicin (PLD)
PLD will be administered at 40-50 mg/m2 (physician discretion) as an intravenous infusion once every 28-days in a 28 day treatment cycle, starting on Cycle 1 Day 1
Interventions
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Alpelisib
Alpelisib will be administered at 200 mg orally once daily following food on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle
Olaparib
Olaparib will be administered at 200 mg orally twice daily irrespective of meals on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.
Paclitaxel
Paclitaxel will be administered at 80 mg/m2 as an intravenous infusion weekly during a 28-day treatment cycle, starting on Cycle 1 Day 1, and on Day 8, Day 15 and Day 22 of every cycle thereafter
Pegylated liposomal doxorubicin (PLD)
PLD will be administered at 40-50 mg/m2 (physician discretion) as an intravenous infusion once every 28-days in a 28 day treatment cycle, starting on Cycle 1 Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)
* If no measurable disease is present, the disease should be assessable by Gynecologic Cancer Intergroup criteria (GCIC) for CA-125
* Participant has no germline BRCA1/2 mutation as determined by an FDA approved assay.
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participant has platinum-resistant (progression within one to six months after completing platinum-based therapy) or platinum refractory disease (progression during treatment or within 4 weeks after the last dose), where platinum-based therapy is not an option, according to the GCIG 5th Ovarian Cancer Consensus Conference definitions. The platinum-based chemotherapy regimen does not necessarily need to be the last regimen the participant received prior to study entry.
* Participant must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment.
* Participant has adequate bone marrow and organ function
Exclusion Criteria
* Participant is concurrently using other anti-cancer therapy
* Participant is in a state of small or large bowel obstruction or has other impairment of gastrointestinal (GI) function or GI disease
* Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects
* Participant has not recovered from all toxicities 5 related to prior anticancer therapies to baseline or NCI CTCAE Version 4.03 Grade ≤1. Exception to this criterion: participants with any grade of alopecia are allowed to enter the study.
* Participants with liver impairment and Child Pugh score B or C
* Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤2 weeks prior to randomization, and who has not recovered to baseline, grade 1 or better from related side effects of such therapy (with the exception of alopecia).
* Participant has a known hypersensitivity to any of the study drugs or excipients
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Arizona Oncology Associates
Phoenix, Arizona, United States
HonorHealth
Phoenix, Arizona, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology P A
Bedford, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology P A
San Antonio, Texas, United States
Texas Oncology Northeast Texas
Tyler, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Ciudad Autonoma de Bs As, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Bedford Park, South Australia, Australia
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Shepparton, Victoria, Australia
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Sydney, , Australia
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Innsbruck, Tyrol, Austria
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Graz, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Chengdu, Sichuan, China
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Beijing, , China
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Jinan, , China
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Shanghai, , China
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Tianjin, , China
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Ostrava, Poruba, Czechia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Herlev, , Denmark
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Odense C, , Denmark
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Besançon, , France
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Lyon, , France
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Paris, , France
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Pierre-Bénite, , France
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Villejuif, , France
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Mannheim, Baden-Wurttemberg, Germany
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Dresden, Saxony, Germany
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Berlin, , Germany
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Essen, , Germany
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Bologna, BO, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Vicenza, VI, Italy
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Napoli, , Italy
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Kuching, Sarawak, Malaysia
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Kuala Lumpur, , Malaysia
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Monterrey, Nuevo León, Mexico
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Mexico City, , Mexico
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Eindhoven, , Netherlands
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Loures, , Portugal
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Porto, , Portugal
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Arkhangelsk, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Bratislava, , Slovakia
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, Catalonia, Spain
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Pamplona, Navarre, Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Izmir, Karsiyaka, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Adana, Yuregir, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Glasgow, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Konstantinopoulos PA, Gonzalez-Martin A, Cruz FM, Friedlander M, Glasspool R, Lorusso D, Marth C, Monk BJ, Kim JW, Hinson P, Ajipa O, Pretre V, Han Y, Matulonis UA. EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). Future Oncol. 2022 Oct;18(31):3481-3492. doi: 10.2217/fon-2022-0666. Epub 2022 Sep 6.
Other Identifiers
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2019-004682-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBYL719K12301
Identifier Type: -
Identifier Source: org_study_id
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