EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Who is this study for? Patients with Ovarian Cancer
Status: Active_not_recruiting
Location: See all (90) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Participant has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

• 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

Locations
United States
Arizona
Arizona Oncology Associates
Phoenix
HonorHealth
Phoenix
Florida
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists
West Palm Beach
Massachusetts
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Maryland
Maryland Oncology Hematology P A
Silver Spring
New York
Memorial Sloan Kettering Cancer Ctr
New York
Ohio
Oncology Hematology Care Inc
Cincinnati
University Of Cincinnati
Cincinnati
South Dakota
Avera Cancer Institute
Sioux Falls
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
Texas Oncology P A
Bedford
Texas Oncology
Dallas
Texas Oncology P A
San Antonio
Texas Oncology Northeast Texas
Tyler
Other Locations
Argentina
Novartis Investigative Site
Buenos Aires
Novartis Investigative Site
Caba
Novartis Investigative Site
Ciudad Autonoma De Bs As
Australia
Novartis Investigative Site
Bedford Park
Novartis Investigative Site
Shepparton
Novartis Investigative Site
Sydney
Austria
Novartis Investigative Site
Graz
Novartis Investigative Site
Innsbruck
Belgium
Novartis Investigative Site
Bruxelles
Novartis Investigative Site
Leuven
Novartis Investigative Site
Namur
Brazil
Novartis Investigative Site
Belo Horizonte
Novartis Investigative Site
Sao Paulo
Canada
Novartis Investigative Site
Calgary
Novartis Investigative Site
London
Novartis Investigative Site
Toronto
Novartis Investigative Site
Vancouver
China
Novartis Investigative Site
Beijing
Novartis Investigative Site
Chengdu
Novartis Investigative Site
Jinan
Novartis Investigative Site
Shanghai
Novartis Investigative Site
Tianjin
Denmark
Novartis Investigative Site
Herlev
Novartis Investigative Site
Odense C
Finland
Novartis Investigative Site
Kuopio
Novartis Investigative Site
Tampere
Novartis Investigative Site
Turku
France
Novartis Investigative Site
Besancon Cedex
Novartis Investigative Site
Lyon
Novartis Investigative Site
Paris
Novartis Investigative Site
Pierre Benite
Novartis Investigative Site
Villejuif
Germany
Novartis Investigative Site
Berlin
Novartis Investigative Site
Dresden
Novartis Investigative Site
Essen
Novartis Investigative Site
Mannheim
Italy
Novartis Investigative Site
Bologna
Novartis Investigative Site
Firenze
Novartis Investigative Site
Milano
Novartis Investigative Site
Milano
Novartis Investigative Site
Napoli
Novartis Investigative Site
Roma
Novartis Investigative Site
Vicenza
Malaysia
Novartis Investigative Site
Kota Kinabalu
Novartis Investigative Site
Kuala Lumpur
Novartis Investigative Site
Kuala Lumpur
Novartis Investigative Site
Kuching
Mexico
Novartis Investigative Site
Ciudad De Mexico
Novartis Investigative Site
Monterrey
Netherlands
Novartis Investigative Site
Eindhoven
Portugal
Novartis Investigative Site
Loures
Novartis Investigative Site
Porto
Republic of Korea
Novartis Investigative Site
Seoul
Novartis Investigative Site
Seoul
Russian Federation
Novartis Investigative Site
Arkhangelsk
Singapore
Novartis Investigative Site
Singapore
Novartis Investigative Site
Singapore
Slovakia
Novartis Investigative Site
Bratislava
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Cordoba
Novartis Investigative Site
Madrid
Novartis Investigative Site
Pamplona
Novartis Investigative Site
Valencia
Taiwan
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taipei
Turkey
Novartis Investigative Site
Adana
Novartis Investigative Site
Ankara
Novartis Investigative Site
Ankara
Novartis Investigative Site
Izmir
United Kingdom
Novartis Investigative Site
Glasgow
Novartis Investigative Site
London
Novartis Investigative Site
Manchester
Time Frame
Start Date: 2021-07-22
Completion Date: 2025-06-04
Participants
Target number of participants: 358
Treatments
Experimental: Alpelisib+olaparib
Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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