Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pancreatic Cancer
- Stereotactic Body Radiation Therapy
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 GC4419 or placebo for treatment of locally advanced pancreatic cancer. Dose-finding will be done using...
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 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 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 Objectives: Primary: • To determine the Maximum Tolerated Dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) when given in combination with placebo or GC4419 Secondary: To evaluate Progression-free survival (PFS) at MTD for patients treated with SBRT given in combination with placebo or GC4419 To evaluate Overall Response Rate (ORR) including stable disease, partial/ complete response for patients treated with SBRT given in combination with placebo or GC4419 To evaluate late (12 month) toxicity of SBRT in combination with placebo or GC4419
Tracking Information
- NCT #
- NCT03340974
- Collaborators
- M.D. Anderson Cancer Center
- Investigators
- Study Chair: Jon Holmlund, MD Galera Therapeutics, Inc.
Get Well Soon