A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 18
- 主要终点
- Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
研究概览
简要总结
This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.
详细描述
Relacorilant is a small-molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of metastatic pancreatic ductal adenocarcinoma.
Eligible patients are those with mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.
Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Relacorilant with nab-paclitaxel
Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
干预措施: Relacorilant, 100 mg and 25 mg (Drug)
Relacorilant with nab-paclitaxel
Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
时间窗: Baseline and up to 32 weeks
Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.
次要结局
- Objective Response Rate (ORR) Per Investigator Assessment(Baseline and up to 48 weeks)
- Best Overall Response (BOR)(Baseline and up to 32 weeks)
- Duration of Response (DOR)(Time of response up to 32 weeks)
- Disease Control Rate (DCR)(Enrollment through 18 weeks)
- Progression-Free Survival (PFS)(Enrollment through 3 months, 6 months, and 12 months)
- Overall Survival (OS)(Enrollment through 3 months, 6 months, and 12 months)
- Cancer Antigen (CA)19-9(Enrollment through 8 weeks and 16 weeks)
- Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria(Enrollment through 6 weeks)
- Time to Progression (TTP)(Baseline and up to 32 weeks)