Clinical trial NCT04698915: Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SBRT
Borderline Resectable Pancreatic Cancer
Unresectable Pancreatic Cancer
Lead sponsor: Galera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Portland
country: United States
facility: Radiation Oncology and Gamma Knife Center of Oregon
state: Oregon
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center (UWMC) - Radiation Oncology Center
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: London
country: Canada
facility: London Regional Cancer Center
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Halifax, Nova Scotia
country: Canada
facility: Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHRU de Brest Hôpital Morvan
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
city: Paris
country: France
facility: Tenon Hospital
city: Pessac
country: France
facility: CHU de Bordeaux, Hôpital Haut-Lévêque
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeenshire
city: Oxford
country: United Kingdom
facility: GenesisCare
state: Oxfordshire
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Imperial College London, Saint Mary's Hospital
Study officials:
References:
citation: Squillace 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.