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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04698915
• Other study ID #: GTI-4711-201
• Status: Terminated
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Galera Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Pancreatic Neoplasms
• SBRT
• Unresectable Pancreatic Cancer

Intervention

Drug:
• Drug GC4711
15 Minute IV Infusion
• Placebo
15 Minute IV Infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)