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Study to assess the efficacy and safety of alpelisib in combination with olaparib in participants with platinum-resistant or refractory gBRCAnm HGSOC
EU CTIS ID: 2024-510782-42-00
What this study is testing
To determine whether treatment with alpelisib in combination with olaparib prolongs PFS compared to single agent cytotoxic chemotherapy in participants with platinum resistant/refractory, gBRCAnm HGSOC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
- Participant has a history of myelodysplastic syndrome or acute myeloid leukemia, or presents clinical and/ or laboratory features suggestive thereof
- 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 adverse 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
See the full eligibility 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 received prior bevacizumab or is not eligible to receive bevacizumab due to medical reasons
- Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
- Participant has a history of myelodysplastic syndrome or acute myeloid leukemia, or presents clinical and/ or laboratory features suggestive thereof
- 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 adverse 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
- Participant has an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose and HbA1c
- 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 adverse effects of such therapy (with the exception of alopecia)
- Participant has a known hypersensitivity to any of the study drugs or excipients
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- China
- Korea, Republic of
- Argentina
- Turkey
- United States
- Canada
- Malaysia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; China; Korea, Republic of; Argentina; Turkey; United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.