2024-516063-89-00
招募中
3 期
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines Inc.16 个研究点 分布在 4 个国家目标入组 80 人开始时间: 2024年12月13日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Revolution Medicines Inc.
- 入组人数
- 80
- 试验地点
- 16
- 主要终点
- PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR. OS is defined as the time from randomization until death from any cause.
概览
简要总结
In the RAS G-12 population (referred to as RAS G12 population): To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: PFS OS
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
- 是
入选标准
- •At least 18 years of age and has provided informed consent. Follow local regulatory requirements if the legal age of consent for study participation is >18 years old.
- •ECOG performance status 0 or
- •Histologically or cytologically confirmed PDAC with metastatic disease
- •Measurable disease per RECIST 1.1
- •Adequate organ function (bone marrow, liver, kidney, coagulation)
- •One prior line of systemic therapy in the metastatic setting.
- •Documented RAS mutation status, either mutant or wild-type. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
- •Able to take oral medications
排除标准
- •Prior therapy with any direct RAS-targeted therapy (eg, degraders and/or inhibitors).
- •History of or known central nervous system metastatic disease.
- •Any conditions that may affect the ability to take or absorb study treatment.
- •Major surgery within 4 weeks prior to randomization.
- •Patient is unable or unwilling to comply with all protocol-required study visits or procedures.
结局指标
主要结局
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR. OS is defined as the time from randomization until death from any cause.
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR. OS is defined as the time from randomization until death from any cause.
次要结局
未报告次要终点
研究者
Zeena Salman
Scientific
Revolution Medicines Inc.
研究点 (16)
Loading locations...
相似试验
已完成
不适用
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
已完成
3 期
SAR408701 versus docetaxel in previously treated, carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) positive metastatic non-squamous non-small-cell lung cancer patients2024-515101-26-00Sanofi-Aventis Recherche & Developpement1
尚未招募
不适用
RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early/Advanced Breast CancerNCT07269691Pengfei Qiu194
招募中
3 期
A Randomized Clinical Trial, Multicentre, Open-label, Parallel-group, to define the best Strategy for the management of hEart failure aNd chronic kidney disease among elderly patients with or at high risk of hyperKalemia in spAin by optimizing the use of RAASi with SZC: SENEKA Study2024-513971-42-00Hospital Clinico Universitario De Valencia94
尚未招募
2 期
ENGIC 01 - COLOSOTO: A single-arm phase II study evaluating 5-fluorouracil plus Panitumumab (anti-EGFR) and Sotorasib (KRAS G12C inhibitor) in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma2024-514030-20-00Fondation Franc.Cancerologie Digestive37