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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04698915
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
SBRT Borderline Resectable Pancreatic Cancer Unresectable Pancreatic Cancer Drug: Drug GC4711 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Median Overall Survival after SBRT completion [ Time Frame: From randomization up to 5 years ]

Secondary Outcome Measures :
  1. Median Progression Free Survival after SBRT Completion per RESIST 1.1 [ Time Frame: From randomization up to 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (m)FOLFIRINOX and SBRT
  3. Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy
  4. Female or male subjects ≥ 18 years of age
  5. ECOG performance status of 0-2
  6. Adequate end-organ function

Exclusion Criteria:

  1. Subjects with documented metastatic disease
  2. First-line chemotherapy other than (m)FOLFIRINOX and/or chemotherapy given for a total period of longer than 4 months prior to start of SBRT
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698915


Contacts
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Contact: Kara Terry 610-725-1500 kterry@galeratx.com
Contact: Jon Holmlund, MD 610-725-1500

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Gary Walker, MD    480-878-2022      
Principal Investigator: Gary Walker, MD         
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719
Contact: Rachna Schroff, MD    520-694-2873      
Principal Investigator: Rachna Schroff, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mitchell Kamrava, MD    310-423-3277      
Principal Investigator: Mitchell Kamrava, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kellie Bodeker    319-384-6332      
Principal Investigator: Joseph Caster, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: David Akhavan    913-588-6046      
Principal Investigator: David Akhavan, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48208
Contact: Parag Parikh, MD    313-916-2600      
Principal Investigator: Parag Parikh, MD         
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Maged Ghaly, MD    516-390-9242      
Principal Investigator: Maged Ghaly, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Manisha Palta, MD    919-684-8111      
Principal Investigator: Manisha Palta, MD         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Erin Anderson    216-844-8447      
Principal Investigator: Jennifer Dorth, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Jaclyn Arterburn    405-271-8001      
Principal Investigator: Sagila George, MD         
United States, Oregon
Radiation Oncology and Gamma Knife Center of Oregon Recruiting
Portland, Oregon, United States, 97210
Contact: Steven Seung, MD    503-215-6800      
Principal Investigator: Steven Seung, MD         
United States, Texas
UT Southwestern Medical Recruiting
Dallas, Texas, United States, 75390
Contact: Liliana Robles    215-645-4673      
Principal Investigator: Todd Aguilera, MD         
United States, Virginia
Blue Ridge Cancer Care Recruiting
Roanoke, Virginia, United States, 24014
Contact: Jessica Nichols    540-808-1704      
Principal Investigator: Mark Kochenderfer, MD         
United States, Washington
Cancer Care Northwest Recruiting
Spokane Valley, Washington, United States, 99216
Contact: Elizabeth Gunderson, MD    509-228-1000      
Principal Investigator: Elizabeth Gunderson, MD         
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon Holmlund, MD Chief Medical Officer
More Information
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04698915    
Other Study ID Numbers: GTI-4711-201
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases