RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 337
- 试验地点
- 108
- 主要终点
- Progression free survival (PFS) PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator. [Time Frame: Up to approximately 2 years]
研究概览
简要总结
To compare the effect of treatment with daraxonrasib monotherapy or daraxonrasib plus GnP versus GnP on: − PFS − OS
研究设计
- 分配方式
- Na
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and has provided informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
- •Documented RAS mutation status, either mutant or wild-type.
- •Measurable disease per RECIST v1.
- •Adequate organ function (bone marrow, liver, kidney, coagulation).
- •Able to take oral medications.
排除标准
- •Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
- •Active or known history of untreated central nervous system metastatic disease.
- •Any conditions that may affect the ability to take or absorb study drug.
- •Major surgery within 28 days prior to randomization.
- •Patient is unable or unwilling to comply with protocol-required study visits or procedures.
研究组 & 干预措施
DARAXONRASIB (RMC-6236), DARAXONRASIB (RMC-6236)
干预措施: DARAXONRASIB (RMC-6236) (Drug)
Abraxane 5 mg/ml powder for dispersion for infusion.
干预措施: Abraxane 5 mg/ml powder for dispersion for infusion. (Drug)
Gemcitabin HEXAL 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: Gemcitabin HEXAL 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Gemcitabin HEXAL 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
结局指标
主要结局
Progression free survival (PFS) PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator. [Time Frame: Up to approximately 2 years]
Progression free survival (PFS) PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator. [Time Frame: Up to approximately 2 years]
Overall survival (OS) OS is defined as the time from randomization until death from any cause. [Time Frame: Up to approximately 2 years]
Overall survival (OS) OS is defined as the time from randomization until death from any cause. [Time Frame: Up to approximately 2 years]
次要结局
- Objective response rate (ORR) Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator. [Time Frame: Up to approximately 2 years]
- Duration of response (DOR) DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the Investigator [Time Frame: Up to approximately 2 years]
- Concentration of daraxonrasib in Arm A and B Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits. [Time Frame: Up to Cycle 5 Day 1 (each cycle is 28 days)]
- Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) Change from baseline in EORTC QLQ-PAN26 pain scale [Time Frame: Up to approximately 2 years]
- Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Change from baseline in EORTC QLQ-C30 global health status [Time Frame: Up to approximately 2 years]
- Incidence of adverse events (AEs) Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 [Time Frame: Up to approximately 2 years]
- Changes in vital signs Changes from baseline in vital signs [Time Frame: Up to approximately 2 years]
- Changes in clinical laboratory test values Changes from baseline in clinical laboratory test values [Time Frame: Up to approximately 2 years]
研究者
Revolution Medicines Study Director
Scientific
Revolution Medicines Inc.