Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem manganese (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

This is a parallel arm adaptive design phase I-II dose-finding study to determine the optimal dose of fractionated stereotactic radiation therapy (SBRT), given either with the radiomodulating agent Avasopasem manganese (GC4419) or placebo for treatment of locally advanced pancreatic cancer. Dose-finding will be done using the sequentially adaptive phase I-II Late onset Efficacy-Toxicity (LO-ET) trade-off-based design \[1-3\]. A maximum of 48 patients will be randomized 1:1 to Arm A or Arm B. Patients in Arm A will receive Avasopasem manganese (GC4419) in combination with their assigned SBRT dose, and patients in Arm B will receive Placebo (PBO) with their assigned SBRT dose. The randomization will be restricted so that the sample size within each arm is exactly 24 patients. GC4419/placebo will be given intravenously in a one hour infusion. SBRT must be initiated as soon as possible upon completion of the GC4419/placebo infusion. GC4419/placebo will be given beginning on the first day of radiation and continuing daily, concurrent M-F throughout the administration of SBRT

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

CTCAE Grade 3 or 4 Gastro-intestinal (GI) Toxicities or Death Within 90 Days From the Start of Therapy [Within 90 days from the start of therapy "related" after CTCAE]. Number, Events. Deaths within 90 days from last dose of study treatment: GC4419 90 mg + 50 Gy (n=18): 1; GC4419 90 mg +55 Gy (n=6): 0; Placebo + 50 Gy SBRT (n=6): 0; Placebo +55 Gy SBRT (n=12): 0. Grade 3 or 4 Gastrointestinal Toxicities: GC4419 90 mg + 50 Gy (n=18): 1; GC4419 90 mg +55 Gy (n=6): 1; Placebo + 50 Gy SBRT (n=6): 0; Placebo +55 Gy SBRT (n=12): 1.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Radiographic Stable Disease (SD) or Better Based on RECIST Criteria [All subjects assessed with at least 12 months of follow up following the administration of SBRT]. Count Of Participants, Participants. Stable Disease: GC4419 90 mg +50 Gy (n=18): 12; GC4419 90mg +55 Gy (n=6): 3; Placebo +50 Gy (n=6): 5; Placebo +55 Gy (n=12): 8. Partial Response: GC4419 90 mg +50 Gy (n=18): 4; GC4419 90mg +55 Gy (n=6): 3; Placebo +50 Gy (n=6): 1; Placebo +55 Gy (n=12): 1. Progressive Disease: GC4419 90 mg +50 Gy (n=18): 0; GC4419 90mg +55 Gy (n=6): 0; Placebo +50 Gy (n=6): 0; Placebo +55 Gy (n=12): 1. Not Evaluated/Censored: GC4419 90 mg +50 Gy (n=18): 2; GC4419 90mg +55 Gy (n=6): 0; Placebo +50 Gy (n=6): 0; Placebo +55 Gy (n=12): 2.