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

NCT04331041 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Verastem, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Carl DeSelm, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2026-02-09
Completion
2027-04-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331041 on ClinicalTrials.gov