A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 24
- 主要终点
- To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab
研究概览
简要总结
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
- •Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
- •Measurable disease per RECIST version 1.
- •Adequate hematologic and organ function as defined by the following criteria:
- •ANC ≥ 1.5 × 10^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
- •Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
- •Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
- •Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
排除标准
- •Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
- •Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
- •Major surgery within 28 days.
- •Radiation therapy within 21 days.
- •Autologous or allogeneic stem cell transplant within 3 months.
- •A serious illness or medical condition(s) including, but not limited to, the following:
- •Brain metastases that require immediate treatment or are clinically or radiographically unstable.
- •Myocardial impairment of any cause.
- •Significant gastrointestinal abnormalities.
- •Active or uncontrolled infection.
- •Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day
- •Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
研究组 & 干预措施
Combination with carboplatin
combined with azenosertib
干预措施: ZN-c3 (Drug)
Combination with carboplatin
combined with azenosertib
干预措施: Carboplatin (Drug)
Combination with PLD
combined with azenosertib
干预措施: ZN-c3 (Drug)
Combination with PLD
combined with azenosertib
干预措施: Pegylated liposomal doxorubicin (Drug)
Combination with paclitaxel
combined with azenosertib
干预措施: ZN-c3 (Drug)
Combination with paclitaxel
combined with azenosertib
干预措施: Paclitaxel (Drug)
Combination with gemcitabine
combined with azenosertib
干预措施: ZN-c3 (Drug)
Combination with gemcitabine
combined with azenosertib
干预措施: Gemcitabine (Drug)
Combination with bevacizumab
combined with azenosertib
干预措施: ZN-c3 (Drug)
Combination with bevacizumab
combined with azenosertib
干预措施: Bevacizumab (Biological)
结局指标
主要结局
To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab
时间窗: Through completion, approximately 40 months
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
时间窗: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)
Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
次要结局
未报告次要终点