Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT04698915

Run by

Galera Therapeutics, Inc.

People needed

177

Starts

2021-05-07

Expected to finish

2023-11-30

Last updated by the study team

2024-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• Northwell Health — Lake Success, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Radiation Oncology and Gamma Knife Center of Oregon — Portland, Oregon, United States
• Pennsylvania State University — University Park, Pennsylvania, United States
• UT Southwestern Medical — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington Medical Center (UWMC) - Radiation Oncology Center — Seattle, Washington, United States
• Cancer Care Northwest — Spokane Valley, Washington, United States
• London Regional Cancer Center — London, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• Institut Bergonié — Bordeaux, France

Full record on ClinicalTrials.gov

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