This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04698915
Recruitment Status : Terminated (Futility Analysis)
First Posted : January 7, 2021
Last Update Posted : December 13, 2023
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE January 7, 2021
Last Update Posted Date December 13, 2023
Actual Study Start Date  ICMJE May 7, 2021
Actual Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
Median Overall Survival after SBRT completion [ Time Frame: From randomization up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
Median Overall Survival after SBRT completion [ Time Frame: From randomization up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
Median Progression Free Survival after SBRT Completion per RESIST 1.1 [ Time Frame: From randomization up to 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • SBRT
  • Borderline Resectable Pancreatic Cancer
  • Unresectable Pancreatic Cancer
Intervention  ICMJE
  • Drug: Drug GC4711
    15 Minute IV Infusion
  • Drug: Placebo
    15 Minute IV Infusion
Study Arms  ICMJE
  • Experimental: Arm A Active GC4711
    Intervention: Drug: Drug GC4711
  • Placebo Comparator: Arm B Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2023)
177
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2021)
160
Actual Study Completion Date  ICMJE November 30, 2023
Actual Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04698915
Other Study ID Numbers  ICMJE GTI-4711-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Galera Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Galera Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galera Therapeutics, Inc.
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP