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.
- Conditions
- high-grade serous ovarian cancerplatinum-resistant or refractory10038594
- Registration Number
- NL-OMON52195
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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 received prior bevacizumab or is not eligible to receive
bevacizumab due to medical reasons as per investigator*s discretion
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 (Wilson et al 2016). 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.
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method