Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer (NCT04698915) | Clinical Trial Compass
TerminatedPhase 2
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Stopped: Futility Analysis
United States177 participantsStarted 2021-05-07
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
ā. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT
ā. Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT
ā. Remain non-metastatic as confirmed by a CT scan at screening.
ā. Female or male subjects ā„ 18 years of age
ā. ECOG performance status of 0-2
ā. Adequate end-organ function
Exclusion criteria
ā. Subjects with documented metastatic disease
ā. First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen
ā. Prior abdominal RT with substantial overlap in radiation fields
ā. Subjects not recovered/controlled from treatment-related toxicities
ā. Uncontrolled malignancy other than PC
ā. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
What they're measuring
1
Overall Survival
Timeframe: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)