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โ† Trials
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Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

RecruitingPhase 3Ages 18 Years - anyAllRevolution Medicines, Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 6 weeks prior to screening. * Documented KRAS G12D mutation status. * 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 unresectable locally advanced or metastatic setting. * Prior systemic RAS-targeted therapy any time prior to randomization. * Presence of other known driver mutations with approved targeted therapies * 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.
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What it tests

  • Zoldonrasib
  • Placebo
  • Oxaliplatin
  • Leucovorin (Calcium Folinate)
  • 5-Fluorouracil
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Where

19 sites
Mayo Clinic Arizona
Phoenix, United States
The University of Arizona Cancer Center-North Campus
Tucson, United States
Yale University
New Haven, United States
University of Florida
Gainesville, United States
Mayo Clinic Florida
Jacksonville, United States
Moffitt Cancer Center
Tampa, United States
Piedmont Cancer Institute
Atlanta, United States
Piedmont Healthcare
Atlanta, United States

โ€ฆand 11 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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