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Phase II Study of Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma

  • Protocol Number: 202106061
  • Principal Investigator: Kim, Hyun
  • Cancer Types: Gastrointestinal

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

Patients with advanced pancreas adenocarcinoma will be randomized on a 6:1 basis to receive standard of care chemotherapy followed by stereotactic body radiotherapy (SBRT) with concurrent and adjuvant FAK inhibitor defactinib (experimental arm) or standard of care chemotherapy followed by SBRT (control arm). Patients enrolled to the experimental arm will be assessed for clinical outcomes such as progression free survival (PFS), local control, distant control, and toxicity. The first 6 patients randomized to the experimental arm will be considered the safety lead-in and will be assessed for dose-limiting toxicities (DLTs). The 6 patients randomized to the control arm will be evaluated for correlatives but will not be included in the analysis for primary and secondary endpoints.

Hypothesis: locally advanced pancreas cancer patients treated with SBRT and concurrent plus adjuvant defactinib will have increased PFS compared to historical rates for patients receiving SBRT alone.

Protocol Interventions

MR-guided stereotactic body radiation therapy, Defactinib, Tumor biopsy, Research blood draw