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

Primary Purpose

SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Drug GC4711
Placebo
Sponsored by
Galera Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • The University of Arizona Cancer Center
  • Cedars-Sinai Medical CenterRecruiting
  • University of MiamiRecruiting
  • Orlando Health Cancer InstituteRecruiting
  • Moffitt Cancer CenterRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kansas Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Mayo Clinic RochesterRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • Hackensack Meridian HealthRecruiting
  • Northwell HealthRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Duke University Medical CenterRecruiting
  • University Hospitals of ClevelandRecruiting
  • Radiation Oncology and Gamma Knife Center of OregonRecruiting
  • Pennsylvania State UniversityRecruiting
  • Texas Oncology
  • UT Southwestern MedicalRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Blue Ridge Cancer Care
  • University of Washington Medical Center (UWMC) - Radiation Oncology CenterRecruiting
  • Cancer Care NorthwestRecruiting
  • London Regional Cancer CenterRecruiting
  • Jewish General HospitalRecruiting
  • Atlantic Clinical Cancer Research Unit/QEII Health Sciences CentreRecruiting
  • Institut BergoniéRecruiting
  • CHRU de Brest Hôpital MorvanRecruiting
  • Centre Georges François LeclercRecruiting
  • Institut régional du Cancer de MontpellierRecruiting
  • Tenon HospitalRecruiting
  • CHU de Bordeaux, Hôpital Haut-LévêqueRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • GenesisCareRecruiting
  • Addenbrookes HospitalRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Imperial College London, Saint Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A Active GC4711

Arm B Placebo

Arm Description

Outcomes

Primary Outcome Measures

Median Overall Survival after SBRT completion

Secondary Outcome Measures

Median Progression Free Survival after SBRT Completion per RESIST 1.1

Full Information

First Posted
January 5, 2021
Last Updated
August 1, 2023
Sponsor
Galera Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04698915
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galera Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A Active GC4711
Arm Type
Experimental
Arm Title
Arm B Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Drug GC4711
Intervention Description
15 Minute IV Infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
15 Minute IV Infusion
Primary Outcome Measure Information:
Title
Median Overall Survival after SBRT completion
Time Frame
From randomization up to 3 years
Secondary Outcome Measure Information:
Title
Median Progression Free Survival after SBRT Completion per RESIST 1.1
Time Frame
From randomization up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Terry
Phone
610-505-7027
Email
kterry@galeratx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Holm
Phone
610-725-1500
Email
mholm@galeratx.com
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Walker, MD
Phone
480-878-2022
First Name & Middle Initial & Last Name & Degree
Gary Walker, MD
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Kamrava, MD
Phone
310-423-3277
First Name & Middle Initial & Last Name & Degree
Mitchell Kamrava, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorriane Portelance, MD
Phone
305-243-4341
First Name & Middle Initial & Last Name & Degree
Lorraine Portelance, MD
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Kelly, MD
Phone
321-841-7413
First Name & Middle Initial & Last Name & Degree
Patrick Kelly, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hoffe, MD
Phone
813-745-6841
First Name & Middle Initial & Last Name & Degree
Sarah Hoffe, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kellie Bodeker
Phone
319-384-6332
First Name & Middle Initial & Last Name & Degree
Joseph Caster, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Akhavan, MD
Phone
913-588-6046
First Name & Middle Initial & Last Name & Degree
David Akhavan, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parag Parikh, MD
Phone
313-916-2600
First Name & Middle Initial & Last Name & Degree
Parag Parikh, MD
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Merrell, MD
Phone
507-538-3828
First Name & Middle Initial & Last Name & Degree
Kenneth Merrell, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem Zaki, MD
Phone
603-650-6600
First Name & Middle Initial & Last Name & Degree
Bassem Zaki, MD
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Miller, MD
Phone
732-776-3466
First Name & Middle Initial & Last Name & Degree
Douglas Miller, MD
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maged Ghaly, MD
Phone
516-390-9242
First Name & Middle Initial & Last Name & Degree
Maged Ghaly, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karyn Goodman, MD
Phone
212-824-7841
First Name & Middle Initial & Last Name & Degree
Karyn Goodman, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD
Phone
919-684-8111
First Name & Middle Initial & Last Name & Degree
Manisha Palta, MD
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Anderson
Phone
216-844-8447
First Name & Middle Initial & Last Name & Degree
Jennifer Dorth, MD
Facility Name
Radiation Oncology and Gamma Knife Center of Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Seung, MD
Phone
503-215-6800
First Name & Middle Initial & Last Name & Degree
Steven Seung, MD
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16082
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Machtay, MD
Phone
717-531-3834
First Name & Middle Initial & Last Name & Degree
Mitchell Machtay, MD
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Withdrawn
Facility Name
UT Southwestern Medical
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Robles
Phone
215-645-4673
First Name & Middle Initial & Last Name & Degree
Todd Aguilera, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cullen Taniguchi, MD
Phone
713-745-3357
First Name & Middle Initial & Last Name & Degree
Cullen Taniguchi, MD
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Washington Medical Center (UWMC) - Radiation Oncology Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim 206-598-4100, MD
Phone
206-598-4100
First Name & Middle Initial & Last Name & Degree
Jim Apisarnthanarax, MD
Facility Name
Cancer Care Northwest
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Gunderson, MD
Phone
509-228-1000
First Name & Middle Initial & Last Name & Degree
Kenneth MacDonald, MD
Facility Name
London Regional Cancer Center
City
London
State/Province
Ontario
ZIP/Postal Code
ON N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Nguyen, MD
Phone
519-685-8500
Ext
53319
First Name & Middle Initial & Last Name & Degree
Timothy Nguyen, MD
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Kavan, MD
Phone
514-340-8222
First Name & Middle Initial & Last Name & Degree
Petr Kavan, MD
Facility Name
Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre
City
Halifax, Nova Scotia
ZIP/Postal Code
B3J 3R4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Ramjeesingh, MD
Phone
902-473-6106
First Name & Middle Initial & Last Name & Degree
Ravi Ramjeesingh, MD
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Batard, MD
Phone
0033 556 333320
First Name & Middle Initial & Last Name & Degree
Sophie Batard, MD
Facility Name
CHRU de Brest Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Metges, MD
Phone
0298223367
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Metges, MD
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Ghirardi, MD
Phone
33380737500
First Name & Middle Initial & Last Name & Degree
Sarah Ghirardi, MD
Facility Name
Institut régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Riou, MD
Phone
33467612322
First Name & Middle Initial & Last Name & Degree
Olivier Riou, MD
Facility Name
Tenon Hospital
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Huguet, MD
Phone
33156018322
First Name & Middle Initial & Last Name & Degree
Florence Huguet, MD
Facility Name
CHU de Bordeaux, Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Vendrely, MD
Phone
0033 557 623320
First Name & Middle Initial & Last Name & Degree
Veronique Vendrely, MD
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2SZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arif Adnan Shaukat, MD
Phone
0345 456 6000
First Name & Middle Initial & Last Name & Degree
Arif Adnan Shaukat, MD
Facility Name
GenesisCare
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX4 6LB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Owens, MD
Phone
01865 706 129
First Name & Middle Initial & Last Name & Degree
Robert Owens, MD
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thankamma Ajithkumar, MD
Phone
01223 274401
First Name & Middle Initial & Last Name & Degree
Thankamma Ajithkumar, MD
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Grose, MD
Phone
0141 301 7000
First Name & Middle Initial & Last Name & Degree
Derek Grose, MD
Facility Name
Imperial College London, Saint Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Ho Edward Park, MD
Phone
0208 383 3089
First Name & Middle Initial & Last Name & Degree
Won-Ho Edward Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34145168
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.
Results Reference
derived

Learn more about this trial

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

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