Daraxonrasib 和 Daraxonrasib + GnP 作为转移性胰腺腺癌患者一线治疗的临床研究 (RASolute 303)
RASolute 303：一项针对转移性胰腺腺癌患者一线治疗的全球、多中心、开放标签、随机、三组、Daraxonrasib单药治疗或Daraxonrasib联合吉西他滨和白蛋白结合型紫杉醇对比吉西他滨和白蛋白结合型紫杉醇的3期研究
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
研究概览
地位
详细说明
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).
研究类型
注册 (估计的)
阶段
- 第三阶段
扩展访问
联系人和位置
学习联系方式
- 姓名：Revolution Medicines Study Director
- 电话号码：1-844-2-REVMED
- 邮箱：medinfo@revmed.com
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 1Z5
- 招聘中
- Princess Margaret Cancer Centre
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Toronto、Ontario、加拿大、M4N 3M5
- 招聘中
- Sunnybrook Research Institute
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Quebec
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Montreal、Quebec、加拿大、H4A 3J1
- 招聘中
- McGill University - Dept. Oncology Clinical Research Program
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Kaohsiung City、台湾、80756
- 招聘中
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
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Taichung、台湾、40447
- 招聘中
- China Medical University Hospital
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Tainan、台湾、704
- 招聘中
- National Cheng Kung University Hospital
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Taipei、台湾、11217
- 招聘中
- Taipei Veterans General Hospital
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Taipei、台湾、100225, R.O.C
- 招聘中
- National Taiwan University Hospital
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-
-
-
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Vienna、奥地利、1020
- 招聘中
- Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien
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-
-
-
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São Paulo、巴西、09060-650
- 招聘中
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Santa Catarina
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Florianópolis、Santa Catarina、巴西、88034-000
- 招聘中
- CEPON - Centro de Pesquisa Oncologicas de Santa Catarina
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接触：
- Victor Fonseca
- 邮箱：contatopesquisa@cepon.org.br
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München、德国、81377
- 招聘中
- Klinikum der Universitaet Muenchen Campus Grosshadern
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-
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Milan、意大利、20133
- 招聘中
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Padova、意大利、35128
- 招聘中
- Istituto Oncologico Veneto IRCCS
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Roma、意大利、00168
- 招聘中
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Tricase、意大利、73039
- 招聘中
- Azienda Ospedaliera Card. G. Panico
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Verona、意大利、37134
- 招聘中
- Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
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-
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Singapore、新加坡、168583
- 招聘中
- National Cancer Centre Singapore
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接触：
- Lee Jie Xin Joycelyn
- 电话号码：6564368000
- 邮箱：clinical.trials@nccs.com.sg
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Singapore、新加坡、217562
- 招聘中
- Curie Oncology Pte Ltd
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接触：
- Hui Shan Chong
- 电话号码：659 829-7005
- 邮箱：huishan_chong@curieresearch.sg
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Chiba、日本、260-8717
- 招聘中
- Chiba Cancer Center
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Fukuoka、日本、812-8582
- 招聘中
- Kyushu University Hospital
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Fukuoka、日本、811-1395
- 招聘中
- NHO Kyushu Cancer Center
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接触：
- Terumasa Hisano
- 电话号码：+81-92-541-3231
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Kanagawa、日本、241-0815
- 招聘中
- Kanagawa Cancer Canter
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接触：
- Makoto Ueno
- 电话号码：+81-45-520-2222
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Osaka、日本、541-8567
- 招聘中
- Osaka International Cancer Institute
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Tokyo、日本、104-0045
- 招聘中
- National Cancer Center - Tokyo
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Wakayama、日本、641-8510
- 招聘中
- Wakayama Medical University Hospital
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接触：
- Reiko Ashida
- 电话号码：+81-73-447-2300
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Yamaguchi、日本、755-8505
- 招聘中
- Yamaguchi University Hospital
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接触：
- Tatsuya Ioka
- 电话号码：+81-836-22-2111
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Chiba
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Kashiwa、Chiba、日本、277-8577
- 招聘中
- National Cancer Center - East
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接触：
- Masafumi Ikeda
- 电话号码：+81-4-7133-1111
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Tokyo
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Koto-Ku、Tokyo、日本、135-8550
- 招聘中
- Cancer Institute Hospital - Japan Foundation for Cancer Research
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接触：
- Masato Ozaka
- 电话号码：+81-3-3520-0111
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-
-
-
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Anderlecht、比利时、1070
- 招聘中
- Institut Jules Bordet
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Leuven、比利时、3000
- 招聘中
- UZ Leuven (Univ Ziekenhuis Leuven)
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-
-
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New South Wales
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Kogarah、New South Wales、澳大利亚、2217
- 招聘中
- St. George Hospital
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Randwick、New South Wales、澳大利亚、2031
- 招聘中
- Prince of Wales Hospital
-
接触：
- Kaye Kongrak
- 电话号码：612-938-25131
- 邮箱：kamonwan.kongrak@health.nsw.gov.au
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Waratah、New South Wales、澳大利亚、2298
- 招聘中
- Calvary Mater Newcastle
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接触：
- Kerrie Cornall
- 电话号码：+61 401 443 282
- 邮箱：kerrie.cornall@health.nsw.gov.au
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Queensland
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Herston、Queensland、澳大利亚、4029
- 招聘中
- Royal Brisbane and Women's Hospital
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Victoria
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East Melbourne、Victoria、澳大利亚、3002
- 招聘中
- Epworth HealthCare
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接触：
- Ashleigh Poh
- 电话号码：613-942-68880
- 邮箱：eh-pancreaticcentre@epworth.org.au
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Heidelberg、Victoria、澳大利亚、3084
- 招聘中
- Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
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Arizona
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Phoenix、Arizona、美国、85054
- 主动，不招人
- Mayo Clinic - Scottsdale
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Scottsdale、Arizona、美国、85258
- 主动，不招人
- Honor Health Research Institute
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California
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Los Angeles、California、美国、90095
- 主动，不招人
- University of California Los Angeles Health - Hematology/Oncology
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San Francisco、California、美国、94158
- 主动，不招人
- University of California San Francisco
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Florida
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Jacksonville、Florida、美国、32224
- 主动，不招人
- Mayo Clinic Cancer Center- Florida
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Tampa、Florida、美国、33612
- 主动，不招人
- H Lee Moffitt Cancer Center and Research Institute
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Maryland
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Baltimore、Maryland、美国、21287
- 主动，不招人
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston、Massachusetts、美国、02215
- 主动，不招人
- Dana-Farber Cancer Institute
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Michigan
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Detroit、Michigan、美国、48202
- 主动，不招人
- Henry Ford Health System
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Minnesota
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Rochester、Minnesota、美国、55905
- 主动，不招人
- Mayo Clinic Cancer Center- Rochester
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Nevada
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Henderson、Nevada、美国、89052
- 主动，不招人
- Comprehensive Cancer Centers of Nevada
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New York
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New York、New York、美国、10065
- 主动，不招人
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Durham、North Carolina、美国、27710
- 主动，不招人
- Duke University Medical Center
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Ohio
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Cincinnati、Ohio、美国、45219
- 主动，不招人
- University of Cincinnati Cancer Center
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Maumee、Ohio、美国、43537
- 主动，不招人
- Taylor Cancer Research Center
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Tennessee
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Nashville、Tennessee、美国、37203
- 主动，不招人
- SCRI Oncology Partners
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Texas
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Dallas、Texas、美国、95246
- 主动，不招人
- SCRI - Texas Oncology Dallas
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Houston、Texas、美国、77030
- 主动，不招人
- MD Anderson Cancer Center
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Utah
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Salt Lake City、Utah、美国、84112
- 主动，不招人
- Huntsman Cancer Institute
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Virginia
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Fairfax、Virginia、美国、22031
- 主动，不招人
- Virginia Cancer Specialists
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Washington
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Seattle、Washington、美国、98101
- 主动，不招人
- Virginia Mason Medical Center
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-
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Birmingham、英国、B15 2TH
- 招聘中
- Queen Elizabeth Hospital - Birmingham
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Cambridge、英国、CB2 0QQ
- 招聘中
- NHS Cambridge of Addenbrooke Hospital
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Liverpool、英国、L7 8YA
- 招聘中
- The Clatterbridge Cancer Centre
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London、英国、W1G 6AD
- 招聘中
- Sarah Cannon Research Institute UK
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接触：
- SCRI Referrals Team
- 电话号码：02032195200 ext 65218
- 邮箱：Referrals.SCRI@hcahealthcare.co.uk
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London、英国、NW3 2QG
- 招聘中
- Royal Free Hospital
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London、英国、SE1 9RT
- 招聘中
- Guy's Hospital
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接触：
- Debashis Sarker
- 邮箱：gstt.giresearchteam@nhs.net
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London、英国、SW3 6JJ
- 招聘中
- Royal Marsden Hospital - London
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London、英国、WC1E 6AG
- 招聘中
- University College London Hospital
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London、英国、EC1A 7BE
- 招聘中
- Barts Hospital
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Manchester、英国、M20 4BX
- 招聘中
- The Christie NHS Foundation Trust
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Devon
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Torquay、Devon、英国、TQ2 7AA
- 招聘中
- Torbay Hospital
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-
-
-
-
Rotterdam、荷兰、3015 GD
- 招聘中
- Erasmus Medisch Centrum
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接触：
- Marjolein Yvonne Veronique Homs
- 电话号码：+31 (0)10 704 17 54
- 邮箱：m.homs@erasmusmc.nl
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Utrecht、荷兰、3543 AZ
- 招聘中
- St. Antonius Ziekenhuis
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接触：
- Geert Anne Cirkel
- 电话号码：+31 (0)88-3206273
- 邮箱：g.cirkel@antoniusziekenhuis.nl
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Madrid、西班牙、28041
- 招聘中
- Hospital Universitario 12 de Octubre
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Madrid、西班牙、28009
- 招聘中
- Hospital General Universitario Gregorio Marañon
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Madrid、西班牙、28064
- 招聘中
- Hospital Universitario La Paz - PPDS
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Valencia、西班牙、46010
- 招聘中
- Hospital Clínico Universitario de Valencia
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-
-
-
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Busan、韩国、49201
- 招聘中
- Dong-A University Hospital
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Seoul、韩国、03080
- 招聘中
- Seoul National University Hospital
-
接触：
- Eunjung Kim
- 邮箱：miwansung@snu.ac.kr
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Seoul、韩国、03722
- 招聘中
- Severance Hospital, Yonsei University Health System
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Seoul、韩国、06351
- 招聘中
- Samsung Medical Center
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接触：
- Hyangsuk Jeong
- 电话号码：82-2-3410-955
- 邮箱：hyangsuk.jeong@samsung.com
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Seoul、韩国、05505
- 招聘中
- Asan Medical Center - PPDS
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Republic of Korea
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Daegu、Republic of Korea、韩国、41404
- 招聘中
- Kyungpook National University Chilgok Hospital
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-
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Sha Tin
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Hong Kong、Sha Tin、香港
- 招聘中
- The Chinese University of Hong Kong
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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 v1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Able to take oral medications.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm A: daraxonrasib
study drug |
oral tablets |
|
实验性的：Arm B: daraxonrasib + gemcitabine and nab-paclitaxel
study drug in combination with chemotherapy |
IV infusion oral tablets intravenous (IV) infusion |
|
有源比较器：Arm C: gemcitabine and nab-paclitaxel
SOC chemotherapy |
IV infusion intravenous (IV) infusion |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival (PFS)
大体时间：Up to approximately 2 years
|
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. |
Up to approximately 2 years
|
|
Overall survival (OS)
大体时间：Up to approximately 2 years
|
OS is defined as the time from randomization until death from any cause. |
Up to approximately 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate (ORR)
大体时间：Up to approximately 2 years
|
Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator. |
Up to approximately 2 years
|
|
Duration of response (DOR)
大体时间：Up to approximately 2 years
|
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. |
Up to approximately 2 years
|
|
Concentration of daraxonrasib in Arm A and B
大体时间：Up to Cycle 5 Day 1 (each cycle is 28 days)
|
Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits. |
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)
大体时间：Up to approximately 2 years
|
EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden. |
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)
大体时间：Up to approximately 2 years
|
EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning. |
Up to approximately 2 years
|
|
Incidence of adverse events (AEs)
大体时间：Up to approximately 2 years
|
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 |
Up to approximately 2 years
|
|
Changes in vital signs
大体时间：Up to approximately 2 years
|
Number of patients with clinically significant changes in vital signs |
Up to approximately 2 years
|
|
Changes in clinical laboratory test values
大体时间：Up to approximately 2 years
|
Number of patients with changes from baseline in clinical laboratory test values |
Up to approximately 2 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.