Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Reason given: Futility Analysis
Key facts
- Where
- Cleveland, Dallas, Detroit, Durham, Gilbert, Hackensack, Houston, Iowa City, Kansas City, Lake Success, Lebanon, Los Angeles, Miami, New York, Orlando, Portland, Rochester, Seattle, Spokane Valley, Tampa, and University Park, United StatesSee the 21 sites
- Phase
- Phase 2
Where in United States
- University Hospitals Of ClevelandCleveland, United StatesNo longer taking part
- UT Southwestern MedicalDallas, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, United StatesNo longer taking part
- Hackensack Meridian HealthHackensack, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Northwell HealthLake Success, United StatesNo longer taking part
- Dartmouth Hitchcock Medical CenterLebanon, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- Orlando Health Cancer InstituteOrlando, United StatesNo longer taking part
- Radiation Oncology and Gamma Knife Center of OregonPortland, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- University of Washington Medical Center (UWMC) - Radiation Oncology CenterSeattle, United StatesNo longer taking part
- Cancer Care NorthwestSpokane Valley, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- Pennsylvania State UniversityUniversity Park, United StatesNo longer taking part
Trial details
- Who runs it
- Galera Therapeutics, Inc.
- Trial code
- NCT04698915
- Record updated
- 21 May 2024
- Original description
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 nonmetastaticRead full original descriptionShow less
GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) 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 OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
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: First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen; Prior abdominal RT with substantial overlap in radiation fields; Subjects with documented metastatic disease; Uncontrolled malignancy other than PC; Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing; Subjects not recovered/controlled from treatment-related toxicities; Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy.