Ovarian Cancer
Conditions
Interventions
Arm 1:
- 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. And Olaparib will be administered at 200
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS based on using RECIST 1.1 criteria | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chech republic, China, Denmark, Finland, France, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Portugal, Russia, Singapore, Slovakia, Spain, Tiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed