Unresectable Pancreatic Cancer Clinical Trial
Official title:
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
| Verified date | December 2023 |
| Source | Galera Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 177 |
| Est. completion date | November 30, 2023 |
| Est. primary completion date | November 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained. 2. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT 3. Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT 4. Remain non-metastatic as confirmed by a CT scan at screening. 5. Female or male subjects = 18 years of age 6. ECOG performance status of 0-2 7. Adequate end-organ function Exclusion Criteria: 1. Subjects with documented metastatic disease 2. First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen 3. Prior abdominal RT with substantial overlap in radiation fields 4. Subjects not recovered/controlled from treatment-related toxicities 5. Uncontrolled malignancy other than PC 6. Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing 7. Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre | Halifax, Nova Scotia | |
| Canada | London Regional Cancer Center | London | Ontario |
| Canada | Jewish General Hospital | Montréal | Quebec |
| France | Institut Bergonié | Bordeaux | |
| France | CHRU de Brest Hôpital Morvan | Brest | |
| France | Centre Georges François Leclerc | Dijon | |
| France | Institut régional du Cancer de Montpellier | Montpellier | |
| France | Tenon Hospital | Paris | |
| France | CHU de Bordeaux, Hôpital Haut-Lévêque | Pessac | |
| United Kingdom | Aberdeen Royal Infirmary | Aberdeen | Aberdeenshire |
| United Kingdom | Addenbrookes Hospital | Cambridge | |
| United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
| United Kingdom | Imperial College London, Saint Mary's Hospital | London | |
| United Kingdom | GenesisCare | Oxford | Oxfordshire |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | UT Southwestern Medical | Dallas | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Hackensack Meridian Health | Hackensack | New Jersey |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Northwell Health | Lake Success | New York |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | University of Miami | Miami | Florida |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Orlando Health Cancer Institute | Orlando | Florida |
| United States | Radiation Oncology and Gamma Knife Center of Oregon | Portland | Oregon |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | University of Washington Medical Center (UWMC) - Radiation Oncology Center | Seattle | Washington |
| United States | Cancer Care Northwest | Spokane Valley | Washington |
| United States | Moffitt Cancer Center | Tampa | Florida |
| United States | Pennsylvania State University | University Park | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Galera Therapeutics, Inc. |
United States, Canada, France, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Median Overall Survival after SBRT completion | From randomization up to 3 years | ||
| Secondary | Median Progression Free Survival after SBRT Completion per RESIST 1.1 | From randomization up to 3 years |
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