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Chemotherapy
SGT-53 + Gemcitabine + nab-paclitaxel for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Minal Barve, MD
Research Sponsored by SynerGene 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 up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for pancreatic cancer. The goal is to see if it is safe, works well, and has few side effects.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Progression free survival (PFS) at 5.5 months
Secondary outcome measures
Adverse events
Disease control rate (DCR)
Duration of disease control
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SGT-53 with gemcitabine/nab-paclitaxelExperimental Treatment3 Interventions
A course of therapy will include 7 weeks of treatment. SGT-53, at 3.6 mg DNA/infusion, will be administered bi-weekly on days 1 and 5 in weeks 1-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7. Patients who are responding to treatment may receive two additional courses (7 weeks) of SGT-53/gemcitabine/nab-paclitaxel therapy at investigator discretion. If still responding to treatment, they may continue on SGT-53/gemcitabine/nab-paclitaxel at investigator discretion with the approval of the sponsor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SGT-53
2008
Completed Phase 1
~30
nab-paclitaxel
2008
Completed Phase 4
~1330
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
SynerGene Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
63 Total Patients Enrolled
Minal Barve, MDPrincipal InvestigatorMary Crowley Cancer Research Center
11 Previous Clinical Trials
377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin levels are not too high.You are taking Coumadin or similar medications, except for keeping your vein access lines open.You are able to perform daily activities without any help or only need a little help.You are expected to live for at least 3 more months.You have severe heart problems or have had a heart attack or unstable chest pain in the past 6 months.You have a fever higher than 38.1°C.You have a type of cancer that affects the blood.Your liver and kidney function tests should be within certain limits: Bilirubin should be less than 1.5 times the upper limit of normal, AST and ALT should be less than 3 times the upper limit of normal, and serum creatinine should be less than 1.5 times the upper limit of normal.Your urine test should not show any important problems.Your blood clotting time is within the normal range.You have not had chemotherapy or experimental treatment before, except if you have already tried FOLFIRINOX and it didn't work, or you had gemcitabine as part of radiation treatment at least 6 months ago and have no ongoing side effects from it.Your organ function is not severely affected.If you are a woman who could become pregnant, you need to have a negative pregnancy test.You have a serious infection that needs strong medicine to control it.You have already received chemotherapy, radiation therapy, surgery, or experimental treatment for your advanced disease.You have been taking strong medications that weaken your immune system in the last 30 days.You are regularly taking medications that help with blood cell production.You have one or more tumors that can be seen on a CT scan.You are able to perform daily activities without any difficulty.You are expected to live for at least 3 more months.You have received a specific type of chemotherapy for pancreatic cancer in the past, unless you have already tried a certain combination of drugs called FOLFIRINOX. If you have taken a different chemotherapy drug called gemcitabine as part of radiation treatment after surgery, that's okay as long as it was at least 6 months ago and you have no lasting side effects. If you have been treated for a different type of cancer, your eligibility will be decided case by case.You have been diagnosed with advanced pancreatic cancer.Your blood counts should be high enough: at least 1500 neutrophils, 100,000 platelets, and 10 grams of hemoglobin per deciliter.Your fasting blood sugar level should be no higher than 160 mg/dL.You have been diagnosed with advanced pancreatic cancer that has spread to other parts of the body.Your blood pressure is consistently high, even with medication.You have a known infection with HIV, Hepatitis B, or Hepatitis C.In the last six months, you have had a stroke, uncontrolled heart failure, severe nerve problems, need for kidney dialysis, received gene therapy, or had a severe allergic reaction to certain medications.You have at least one tumor that can be measured using a CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: SGT-53 with gemcitabine/nab-paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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