Phase 1b Window-of-Opportunity Study Evaluating CDK7 Inhibition in Patients With Localized Basal Pancreatic Cancer
University of Washington
Summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.
Description
This is a single-institution, single-arm, open-label, Phase 1 study designed to evaluate whether samuraciclib, a cyclin dependent kinase 7 inhibitor (CDK7), alters the cellular functioning of the pancreatic tumor cells. OUTLINE: Patients will receive samuraciclib orally (PO) once daily (QD) for 14 days on study following their diagnosis of pancreatic cancer and before starting chemotherapy or undergoing surgery for their cancer. Patients will undergo an endoscopic ultrasound (EUS) with fine needle biopsy (FNB) while on study. After completion of study treatment, patients are followed up at…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible. * Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei * Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of positron emission tomography (P…
Interventions
- DrugSamuraciclib
Given PO
- ProcedureComputed Tomography
Undergo CT
- ProcedureEndoscopic Ultrasound Biopsy
Undergo EUS/FNB
- ProcedureBiospecimen Collection
Undergo blood sample collection
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington