EUCTR2019-004682-40-BE进行中（未招募）1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 358
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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 (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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 179
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 179
排除标准
- •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 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.
- •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.
研究者
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