Dana-Farber Cancer Institute
This Phase 1 interventional treatment study is evaluating oral daraxonrasib in participants with resectable pancreatic ductal adenocarcinoma. The study includes pre-surgery daraxonrasib treatment, surgery, adjuvant chemotherapy with or without radiation, optional adjuvant daraxonrasib, and follow-up. The protocol also includes research blood, stool, tissue, and de-identified data collection for correlative and future research.
This is a DF/HCC PI-sponsored Phase 1 interventional treatment trial in resectable pancreatic ductal adenocarcinoma. Participants are screened before starting treatment and then assigned to one of two protocol-defined cohorts that differ in the duration of neoadjuvant daraxonrasib before surgery. Study treatment includes oral daraxonrasib once daily during 28-day cycles before surgery, followed by surgical resection, adjuvant chemotherapy with or without radiation per institutional standard and physician discretion, and optional adjuvant daraxonrasib for up to 32 cycles (24 months) after compl…
Inclusion Criteria: * The clinical, radiographic, and pathologic evidence support a diagnosis of pancreatic adenocarcinoma, with histology confirmatory for adenocarcinoma, adenosquamous carcinoma, or poorly differentiated carcinoma. * Subjects must be determined to meet the criteria for resectable pancreatic cancer based on National Comprehensive Cancer Network (NCCN) criteria at initial diagnosis (Table 2). Patients with borderline resectable, locally advanced, or metastatic disease are not eligible for this trial. Resectability status * Resectable * Borderline resectable * Locally advance…
Oral study drug taken once daily in 28-day cycles at a predetermined dose before surgery, and optionally again in the adjuvant setting after completion of adjuvant therapy.
Protocol-planned surgery performed after neoadjuvant daraxonrasib treatment and surgical planning.
Post-surgery chemotherapy administered per institutional standard and investigator/physician discretion.
Post-surgery radiation therapy may be given with adjuvant chemotherapy according to institutional standard and investigator/physician discretion.
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Actual pay is set by the research site.
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