Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT04698915
Recruitment Status :
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
Condition or disease
SBRTBorderline Resectable Pancreatic CancerUnresectable Pancreatic Cancer
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
Remain non-metastatic as confirmed by a CT scan at screening.
Female or male subjects ≥ 18 years of age
ECOG performance status of 0-2
Adequate end-organ function
Subjects with documented metastatic disease
First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
Prior abdominal RT with substantial overlap in radiation fields
Subjects not recovered/controlled from treatment-related toxicities
Uncontrolled malignancy other than PC
Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy