Study Stopped
Futility Analysis
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
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
1 other identifier
interventional
177
4 countries
35
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 unresectable or borderline resectable nonmetastatic
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedResults Posted
Study results publicly available
May 21, 2024
CompletedMay 21, 2024
April 1, 2024
2.6 years
January 5, 2021
March 1, 2024
April 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
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)
Study Arms (2)
Arm A Active GC4711
EXPERIMENTALArm B Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Miami
Miami, Florida, 33146, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Henry Ford Hospital
Detroit, Michigan, 48208, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Northwell Health
Lake Success, New York, 11042, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Radiation Oncology and Gamma Knife Center of Oregon
Portland, Oregon, 97210, United States
Pennsylvania State University
University Park, Pennsylvania, 16082, United States
UT Southwestern Medical
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington Medical Center (UWMC) - Radiation Oncology Center
Seattle, Washington, 98195, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216, United States
London Regional Cancer Center
London, Ontario, ON N6A 5W9, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre
Halifax, Nova Scotia, B3J 3R4, Canada
Institut Bergonié
Bordeaux, France
CHRU de Brest Hôpital Morvan
Brest, 29200, France
Centre Georges François Leclerc
Dijon, 21079, France
Institut régional du Cancer de Montpellier
Montpellier, 34090, France
Tenon Hospital
Paris, 75020, France
CHU de Bordeaux, Hôpital Haut-Lévêque
Pessac, 33600, France
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2SZ, United Kingdom
GenesisCare
Oxford, Oxfordshire, OX4 6LB, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Imperial College London, Saint Mary's Hospital
London, W2 1NY, United Kingdom
Related Publications (3)
Hoffe SE, Aguilera TA, Parikh PJ, Ghaly MM, Herman JM, Caster JM, Kim DW, Costello J, Malafa MP, Moser EC, Kennedy EP, Terry K, Kurman M. Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design. Future Oncol. 2024 Mar;20(8):437-446. doi: 10.2217/fon-2022-1219. Epub 2024 Jan 24.
PMID: 38264869DERIVEDTaniguchi CM, Frakes JM, Aguilera TA, Palta M, Czito B, Bhutani MS, Colbert LE, Abi Jaoude J, Bernard V, Pant S, Tzeng CD, Kim DW, Malafa M, Costello J, Mathew G, Rebueno N, Koay EJ, Das P, Ludmir EB, Katz MHG, Wolff RA, Beddar S, Sawakuchi GO, Moningi S, Slack Tidwell RS, Yuan Y, Thall PF, Beardsley RA, Holmlund J, Herman JM, Hoffe SE. Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial. Lancet Oncol. 2023 Dec;24(12):1387-1398. doi: 10.1016/S1470-2045(23)00478-3.
PMID: 38039992DERIVEDSquillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
PMID: 34145168DERIVED
Limitations and Caveats
Study was terminated early by the Sponsor based on a futility analysis that was conducted in which the trial met the prespecified early termination rules. The last randomized subject did not complete protocol therapy but was followed for safety for a period of 30 days post the last administration of GC4711/Placebo +SBRT.
Results Point of Contact
- Title
- Judy Schnyder, Sr. Vice President Clinical Operations and Data Management
- Organization
- Galera Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 7, 2021
Study Start
May 7, 2021
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
May 21, 2024
Results First Posted
May 21, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share