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

December 6, 2023 updated by: Galera Therapeutics, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Halifax, Nova Scotia, Canada, B3J 3R4
        • Atlantic Clinical Cancer Research Unit/QEII Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, ON N6A 5W9
        • London Regional Cancer Center
    • Quebec
      • Montréal, Quebec, Canada
        • Jewish General Hospital
  • France
      • Bordeaux, France
        • Institut Bergonié
      • Brest, France, 29200
        • CHRU de Brest Hôpital Morvan
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Montpellier, France, 34090
        • Institut Régional du Cancer de Montpellier
      • Paris, France, 75020
        • Tenon Hospital
      • Pessac, France, 33600
        • CHU de Bordeaux, Hôpital Haut-Lévêque
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, W2 1NY
        • Imperial College London, Saint Mary's Hospital
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2SZ
        • Aberdeen Royal Infirmary
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX4 6LB
        • GenesisCare
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48208
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Health
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97210
        • Radiation Oncology and Gamma Knife Center of Oregon
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16082
        • Pennsylvania State University
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center (UWMC) - Radiation Oncology Center
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A Active GC4711
Drug: Drug GC4711
15 Minute IV Infusion
Placebo Comparator: Arm B Placebo
Drug: Placebo
15 Minute IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median Overall Survival after SBRT completion
Time Frame: From randomization up to 3 years
From randomization up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Median Progression Free Survival after SBRT Completion per RESIST 1.1
Time Frame: From randomization up to 3 years
From randomization up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galera Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTI-4711-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unresectable Pancreatic Cancer

Clinical Trials on Drug GC4711

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe