NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resecta… (NCT04484909) | Clinical Trial Compass
SuspendedPhase 1
NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer
Stopped: PI Request
United States24 participantsStarted 2020-07-01
Plain-language summary
To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
✓. Age ≥ 18 years
✓. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
✓. Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed:
✓. gemcitabine/nab-paclitaxel
✓. gemcitabine/capecitabine
✓. gemcitabine/cisplatin
✓. gemcitabine
Exclusion criteria
✕. Prior radiation therapy to the upper abdomen
✕. Prior surgical resection of pancreatic tumor
✕. Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study.
✕. LAPC or BRPC with radiographic evidence of distant metastasis at screening.
✕. Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4)
✕. Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
✕. Known contraindication to iodine-based or gadolinium-based IV contrast
✕. Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis