NCT04331041

Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor in Advanced Pancreas Adenocarcinoma

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced pancreas adenocarcinoma will be randomized on a 6:1 basis to receive standard of care chemotherapy followed by adaptive 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 initial 6 patients randomized to the experimental arm will be considered the safety lead-in and will be assessed for dose-limiting toxicities (DLTs). Following completion of the safety lead-in, additional patients will be accrued in order to reach a total of 36 patients on the experimental arm (inclusive of the safety lead-in cohort) and 6 on the control arm.

Conditions

• Pancreas Cancer
• Cancer of the Pancreas
• Pancreas Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Adaptive stereotactic body radiation therapy	* Will be administered using MRIdian and Ethos * 50 Gy in 5 fractions
DRUG	Defactinib	-Oral drug 400 mg twice a day
PROCEDURE	Tumor biopsy	-Baseline and 12-14 weeks after end of SBRT (or at time of surgery)
PROCEDURE	Research blood draw	-Baseline, 6-8 weeks after the end of SBRT, and 12-14 weeks after the end of SBRT

Timeline

• Start date: 2021-08-24
• Primary completion: 2026-02-09
• Completion: 2027-04-21
• First posted: 2020-04-02
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study