Clinical Trial 21038

• Overview

  Study Title:

  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

  Summary:

  GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to overall survival by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

  Objective:

  Primary: To determine the effect on progression-free survival (PFS) of adding GC4711 to SBRT compared to placebo after 4 months of chemotherapy in subjects with unresectable or borderline resectable nonmetastatic pancreatic cancer (PC) Secondary: To determine the effect of adding GC4711 to SBRT on: Overall survival (OS), locoregional control (LRC), and time to distant metastases (TDM). Surgical exploration rates and outcomes Acute and late toxicity observed after SBRT

• Treatments

  Therapies:

  Radiotherapy; Therapy (NOS)

  Medications:

  FOLFIRINOX (); GC4711/Placebo (); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Taxol (paclitaxel); cisplatin (); gemcitabine (); paclitaxel ()

• Inclusion Criteria

  • Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained.
  • Newly diagnosed non-metastatic PC judged by site's multidisciplinary review to be feasible for SBRT, as well as having measurable disease as defined by RECIST 1.1
  • Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT.
  • Remains non-metastatic (i.e., M0 disease) after 3 months of chemotherapy (response evaluation on CT scan performed 2.5-3.5 months from start of chemotherapy.
  • Female or male subjects > 18 years of age
  • ECOG performance status of 0-2
  • Adequate end-organ function

• Exclusion Criteria

  • Subjects with documented metastatic disease
  • First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen. Subjects receiving either regimen after initial gemcitabine monotherapy are eligible
  • Prior abdominal RT with substantial overlap in radiation fields
  • Subjects not recovered/controlled from treatment-related toxicities
  • Uncontrolled malignancy other than PC
  • Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing
  • Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy
  • Subjects with Gilbert syndrome who are known to be homozygous for the UGT1A polymorphism
  • Subjects with hypokalemia whose QT/QTc interval > 470 ms (for women) and > 450 ms (for men) on the screening ECG at visit
  • Treatment with any investigational drug outside this protocol since diagnosis until disease progression given for the disease in study. Prior to the enrollment of subjects on other investigational agents, Sponsor's written approval must be obtained
  • Subjects who have already undergone resection of their pancreatic tumors.

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