EUCTR2017-004009-42-BE进行中（未招募）1 期
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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.
- •- 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). Note that the biopsy may be collected prior to the predose Cycle 1 Day 1 pregnancy test and labs.
- •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 a known serious medical condition (e.g., active infection, increased risk of bleeding events) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol or tolerate the study treatment.
- •- Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
- •- 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 and topical steroids.
研究者
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