Clinical Trials /

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

NCT04698915

Description:

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

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: GTI-4711-201
  • NCT ID: NCT04698915

Conditions

  • SBRT
  • Borderline Resectable Pancreatic Cancer
  • Unresectable Pancreatic Cancer

Interventions

DrugSynonymsArms
Drug GC4711Arm A Active GC4711
PlaceboArm B Placebo

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm A Active GC4711Experimental
  • Drug GC4711
Arm B PlaceboPlacebo Comparator
  • Placebo

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Median Overall Survival after SBRT completion
Time Frame:From randomization up to 5 years
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Galera Therapeutics, Inc.

Last Updated

July 6, 2021