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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 : August 3, 2023
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 3 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 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
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 610-505-7027 kterry@galeratx.com
Contact: Megan Holm 610-725-1500 mholm@galeratx.com

Locations
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Sponsors and Collaborators
Galera Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: August 3, 2023
Last Verified: August 2023
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