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

GRECO-2: A Randomized, Phase 2 Study of Stereotactic Body Radiation Therapy (SBRT) in combination with GC4711 in the Treatment of Unresectable or Borderline Resectable, Nonmetastatic Pancreatic Cancer

  • Clinical Trial Information

    Trial Contact: Simoni, Christine; Frankos, Marie; Caldwell, Chloe M

  • IRB No: S22.121.06

    Protocol Abbrev: GRECO-2

    Principal Investigator: Patrick Kelly, MD, PhD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: GTI-4711-201

    Treatment: Experimental: Arm A Active GC4711 (15 Minute IV Infusion) Placebo Comparator: Arm B Placebo (15 Minute IV Infusion)

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04698915

  • Objective

    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.

  • Key Eligibility

    -Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.

    -Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT

    -Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT

    -Remain non-metastatic as confirmed by a CT scan at screening.

    -Female or male subjects ≥ 18 years of age

    -ECOG performance status of 0-2

    -Adequate end-organ function