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SGT-53 + Gemcitabine + nab-paclitaxel for Pancreatic Cancer
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.
- Pancreatic Cancer
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: SGT-53 with gemcitabine/nab-paclitaxel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What benefits does this clinical trial hope to bring patients?
"According to the study sponsor, SynerGene Therapeutics, Inc., the primary outcome being measured over a 5.5-month period is Objective Response Rate (ORR). Additionally, this trial will evaluate secondary outcomes such as Disease Control Rate (DCR) –– which is defined as Disease control rate (SD for ≥16 weeks plus CR and PR) –– using Kaplan-Meier methods; Adverse Events –– defined as Safety evaluated by the incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), physical examination, laboratory abnormalities during study drug dosing and percentage of patients"
Is this the first time SGT-53 has been used in a human clinical trial?
"As of now, 1191 different clinical trials are assessing the efficacy of SGT-53. Out of these, 334 have reached Phase 3. The global distribution for these studies is quite broad with 60110 locations running active investigations."
Can new participants still join this experiment?
"Currently, this study is looking for volunteers. The clinicaltrials.gov website shows that the original posting was on January 1st, 2015 and the most recent update was February 7th, 2022."
What medical condition does SGT-53 target?
"SGT-53 is most often used to treat locally advanced non-small cell lung cancer, but it also has potential benefits for patients with metastatic bladder cancer, urinary bladder conditions, and mediastinitis."
When will SGT-53 be available for general use?
"SGT-53 falls into Phase 2 of clinical trials. This means that while there is evidence pointing towards the safety of this medication, there are no studies yet affirming its efficacy."
How many guinea pigs are part of this testing process?
"That is accurate. According to the information on clinicaltrials.gov, this particular trial has 28 open slots for patients across 1 enrolment site. The listing was created on 01/01/2015 and last updated on 02/07/2022."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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