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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04331041
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Cancer of the Pancreas
  • Pancreas Adenocarcinoma
  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 24, 2021
Status verified
May 2026
Primary completion
Feb 9, 2026
Completion
Apr 21, 2027

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adaptive SBRT + Defactinib
    * Participants in this study will receive 5 fractions of magnetic resonance adaptive stereotactic body radiation therapy (SBRT) and seventeen 21-day cycles of defactinib (beginning on Day 2 of radiation). * Participants who are candidates for surgical resection will undergo standard of care surgery at 2 weeks post-end of SBRT (+/- 1 weeks) or 12 weeks post-end of SBRT (+/- 1 week). These participants will discontinue defactinib the day prior to the operation and will resume taking it for the remainder of the 17 cycles 4 to 6 weeks after surgery. Participants who are not candidates for surgical resection will continue to receive defactinib uninterrupted. All participants should receive 17 cycles of defactinib unless they experience disease progression or intolerable toxicity.
  • Active Comparator: Adaptive SBRT
    -Participants in this study will receive 5 fractions of magnetic resonance adaptive stereotactic body radiation therapy (SBRT)

Primary Outcome Measure

Progression-free survival (PFS) (Experimental Arm only) [ Time Frame: After completion of treatment (estimated to be 12 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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Washington University School of Medicine· St Louis, MO

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