GRECO-2: A Randomized, Phase 2 Study of Stereotactic Body Radiation Therapy (SBRT) in combination with GC4711 in the Treatment of Unresectable or Borderline Resectable, Nonmetastatic Pancreatic Cancer
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to overall survival by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
Primary: To determine the effect on progression-free survival (PFS) of adding GC4711 to SBRT compared to placebo after 4 months of chemotherapy in subjects with unresectable or borderline resectable nonmetastatic pancreatic cancer (PC)
Secondary: To determine the effect of adding GC4711 to SBRT on:
Overall survival (OS), locoregional control (LRC), and time to distant metastases (TDM).
Surgical exploration rates and outcomes
Acute and late toxicity observed after SBRT
First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen. Subjects receiving either regimen after initial gemcitabine monotherapy are eligible
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
Subjects with Gilbert syndrome who are known to be homozygous for the UGT1A polymorphism
Subjects with hypokalemia whose QT/QTc interval > 470 ms (for women) and > 450 ms (for men) on the screening ECG at visit
Treatment with any investigational drug outside this protocol since diagnosis until disease progression given for the disease in study. Prior to the enrollment of subjects on other investigational agents, Sponsor’s written approval must be obtained
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