2024-514714-12-00已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 62
- 主要终点
- OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.
研究概览
简要总结
The primary objective of the study is to compare overall survival (OS) between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- •Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel.
- •Life expectancy ≥3 months.
- •Adult, age ≥ 18 years, male or female.
- •Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception. Male subjects with partners who are oCBP should also use a highly effective contraceptive measure during the study and through 6 months following the last administration of study drug.
- •Adequate bone marrow, hepatic, renal, and coagulation function
- •QTc interval of ≤ 470 msec ms (for women) and ≤ 450 ms (for men) on the ECG baseline calculated by either the Fridericia or Framingham formula.
- •Willing and able to provide written informed consent
排除标准
- •1.Subjects known to have mutations of the BRCA1/2 (Breast Cancer gene).
- •Concomitant metformin administration.
- •History of noncompliance or any previous or concomitant disease, condition and/or medication that might compromise the subject's ability to give informed consent, make it undesirable for the subject to participate in the study, would jeopardize the participant's safety or compliance with the protocol or might interfere with the reliability of the data collected.
- •Pregnant or lactating.
- •Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- •Known hypersensitivity to any component of study drug treatments.
- •Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug. Participation in observational trials is not excluded.
结局指标
主要结局
OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.
OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.
次要结局
- PFS defined as time until disease progression or death from any cause, whichever occurs first. ORR defined as percentage of subjects with a best overall response of CR or PR, determined using RECIST 1.1 criteria. DCR defined as percentage of subjects with confirmed CR, PR, or SD for at least 16 weeks. DoR in subjects who achieve a CR or PR, defined as time from onset of first CR or PR until disease progression or death from any cause. QoL, assessed using EORTC QLQ-30 and QLQ-PAN26 questionnaires
研究者
Scientific contact point
Scientific
Panbela Therapeutics Inc.
研究点 (62)
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