EUCTR2017-004009-42-ES进行中（未招募）1 期
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
illy S.A.0 个研究点目标入组 169 人开始时间: 2018年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 169
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Women who have histologically or cytologically verified high-grade serous ovarian,
- •primary peritoneal or fallopian tube cancer.
- •- Cohorts 1 to 3: Have platinum-resistant disease, which is defined as disease
- •progression within 6 months of last dose of platinum-based chemotherapy.
- •- Cohort 4: Have primary platinum-refractory disease defined as disease progression
- •during or within 4 weeks after the last dose of initial line of platinum-based
- •chemotherapy for ovarian cancer.
- •- Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy for
- •high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
- •immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
- •- Cohort 2: Are BRCA negative have received less than 3 prior lines of therapy for
- •high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
- •immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
- •- Cohort 3: Are BRCA positive and have previously received a PARP inhibitor at any
- •time following diagnosis.
- •- Cohort 4: Are BRCA positive or negative; no restriction on number of lines of prior
- •- Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group
- •(ECOG) scale
- •- Have adequate organ function,
- •- Must be able and willing to undergo mandatory tumor biopsy which will be collected following determination of eligibility and before treatment (=28 days before C1D1).
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Cohorts 1-3: Have previously received all of the following agents at any time in the
- •platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
- •paclitaxel. It is acceptable to have received 1 or 2 of these agents for platinumresistant
- •- Have known central nervous system (CNS) malignancy or metastasis.
- •- Have at least one of the following:
- •history of abdominal fistula or gastrointestinal (GI) perforation
- •intra-abdominal abscess within last 3 months prior to the first dose of study drug
- •a radiographically confirmed bowel obstruction (including sub-occlusive disease)
- •within 3 months prior to the first dose of study drug.
- •- Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic
- •activated/reactivated hepatitis A, B, or C (screening is not required).
- •- Have a serious cardiac condition, such as:
- •symptomatic congestive heart failure or any uncontrolled cardiac disease
- •New York Heart Association Class III/IV heart disease
- •unstable angina pectoris
- •symptomatic or poorly controlled cardiac arrhythmia
- •myocardial infarction within the last 3 months
- •have a QT interval using Fridericia’s correction (QTcF) of >480 msec on more
- •than one electrocardiogram (ECG) obtained during the baseline (screening) period
- •family history of long-QT syndrome.
- •- Have a history of prior radiotherapy to the whole pelvis.
- •- Have chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone
- •equivalent), excluding inhaled steroids.
研究者
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