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GC4711 + SBRT for Pancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by Galera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 3 years
Summary
This trial is testing a new drug called GC4711 to see if it can improve the results of a precise radiation therapy for patients whose cancer cannot be easily removed by surgery. The goal is to find out if adding GC4711 makes the radiation treatment more effective. This could help patients with difficult-to-remove cancers live longer.
Eligible Conditions
- Pancreatic Cancer
- Stereotactic Body Radiation Therapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Median Progression Free Survival after SBRT Completion per RESIST 1.1
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A Active GC4711Experimental Treatment1 Intervention
Group II: Arm B PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Galera Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,173 Total Patients Enrolled
Jon Holmlund, MDStudy ChairChief Medical Officer
6 Previous Clinical Trials
213 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a stomach or small intestine ulcer that is not under control within the last 30 days.You have been diagnosed with pancreatic cancer confirmed by a tissue sample or, if not possible, by a fluid sample.You are able to perform daily activities without being limited by your health.Your organs are working properly.The tumor is clearly invading the inside of the bowel or stomach, as seen during an endoscopy.You have a type of cancer that is not prostate cancer and it is not under control.You have been diagnosed with advanced stage of cancer that has spread to other parts of the body.You have not received certain types of chemotherapy as your first treatment for the condition.You have received significant radiation treatment in your abdomen in the past.A CT scan has shown that the cancer has not spread to other parts of the body.You have been diagnosed with prostate cancer that has not spread to other parts of the body, and a tumor board has determined that you can receive a type of radiation treatment called SBRT.You have finished at least 6 weeks of specific chemotherapy treatments before starting a type of radiation therapy called SBRT.You have not fully recovered from side effects caused by previous treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Active GC4711
- Group 2: Arm B Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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