Status:
TERMINATED
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
SBRT
Borderline Resectable Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04698915
Start Date
May 7 2021
End Date
November 30 2023
Last Update
May 21 2024
Active Locations (35)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of Miami
Miami, Florida, United States, 33146
4
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806