NCT03340974 - Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 12, 2018

Primary Completion Date

August 21, 2020

Study Completion Date

May 26, 2021

Conditions

Pancreatic CancerStereotactic Body Radiation Therapy

Interventions

DRUG

GC4419

90 mg Avasopasem (GC4419) per day daily (60 min IV infusion, prior to SBRT), concurrent with daily fractions of SBRT to assigned dose level

DRUG

Placebo

Placebo daily (60 min IV infusion, prior to SBRT), concurrent with daily fractions of SBRT to assigned dose level

RADIATION

Stereotactic Radiation Therapy (SBRT) 50 Gy

Dose-finding will be done using the sequentially adaptive phase I-II Late onset Efficacy-Toxicity (LO-ET) trade-off-based design.

RADIATION

Stereotactic Radiation Therapy (SBRT) 55 Gy

Dose-finding will be done using the sequentially adaptive phase I-II Late onset Efficacy-Toxicity (LO-ET) trade-off-based design.

Trial Locations (6)

Duke University Medical Center, Durham

Moffitt Cancer Center, Tampa

UT Southwestern Medical Center, Dallas

The University of Texas MD Anderson Cancer Center, Houston

Dana Farber Cancer Institute, Boston

Atlantic Health System / Morristown Medical Center, Morristown