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Zolbetuximab + Chemotherapy for Pancreatic Cancer
Study Summary
This trial is testing a new cancer treatment and will measure how well it works, how long patients live, and how safe it is.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.I have severe fluid buildup in my chest or abdomen.You can participate in the study if your hepatitis C blood test shows that you had the infection in the past, but the virus is not currently in your body.I do not have active hepatitis B according to my test results.Your albumin levels are at least 2.5 grams per deciliter.I was treated for hepatitis C and now have no detectable virus.I am fully active or restricted in physically strenuous activity but can do light work.Your total bilirubin level in the blood should be less than 1.5 times the upper limit of normal.My pancreatic cancer has spread to my brain or its coverings.You have tested positive for HIV, hepatitis B, or hepatitis C.I agree not to breastfeed during and for 6 months after the study.I have had fluorouracil or GEM with radiation therapy.My cancer returned or got worse 6 months after finishing my last cancer prevention treatment.I am allergic to zolbetuximab or similar medications.My tumor shows high CLDN18.2 expression.I have moderate to severe nerve damage in my hands or feet, not just from missing reflexes.I have not fully recovered from a major surgery within the last 2 weeks.My pancreatic cancer has spread and I haven't had chemotherapy.I need treatment for another type of cancer.I will not donate sperm during or for 6 months after the study.My cancer is a type of pancreatic cancer called adenocarcinoma.I haven't taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or a one-time use.I have serious heart issues or had a major heart event in the last 6 months.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.I had radiation for pancreatic cancer less than 2 weeks ago and still have side effects.Your hemoglobin level is at least 9 grams per deciliter, and you have not had a blood transfusion in the past 14 days.Your white blood cell count is at least 1.5 x 10^9/L.I will not donate eggs during and for 6 months after the study.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 6 months after the study.My condition did not worsen after treatment with Nab-P and GEM.I have had interstitial pneumonia or pulmonary fibrosis.My condition did not worsen after treatment with Nab-P and GEM.Your blood clotting time is within a certain range, unless you are already taking medication to prevent blood clots.I have an autoimmune disease and have received treatment for it in the last 3 months.My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).I am a man who will use birth control during and for 6 months after the study.I have an infection needing treatment that hasn't fully cleared in the last week.I had major surgery less than 28 days ago.I have received 5-FU or GEM with radiation therapy.Your platelet count is at least 100 billion per liter.My liver function tests are within the required range.
- 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.
- Group 1: zolbetuximab +nab-paclitaxel + gemcitabine
- Group 2: nab-paclitaxel + gemcitabine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
What outcomes is this trial hoping to achieve?
"According to Astellas Pharma Global Development, Inc., the primary outcome for this trial will be Safety determined by Serious Adverse Events (SAE) over an up to 65 month time-frame. Additionally, secondary objectives involve measuring Objective Response Rate (ORR), Paclitaxel's Time of Maximum Concentration (Tmax), and Area Under the Concentration-time Curve from Time of Dosing Until Last Measurable Concentration (AUClast)."
Have prior studies demonstrated the efficacy of nab-paclitaxel?
"The City of Hope Comprehensive Cancer Center initiated research on nab-paclitaxel in 1997, and a total of 1861 trials have been completed. Currently, there are 1116 existing medical studies being conducted at various locations around Olympia, Washington."
What adverse effects are associated with the use of nab-paclitaxel?
"There is some evidence for nab-paclitaxel's safety, so it was rated a 2. However, there is yet to be any clinical data demonstrating its efficacy."
Is enrollment in this clinical trial still possible?
"Affirmative. The data hosted on clinicaltrials.gov reveals that this research endeavour, which was initially advertised on March 15th 2019, is actively seeking participants. A total of 369 patients need to be recruited from 16 distinct healthcare facilities."
How widely is this clinical trial distributed among hospitals in the state?
"Currently, the research is enrolling participants at 16 sites spread across multiple states. To reduce travel needs, those interested in joining should select a clinic closest to their current location from Olympia, Salt Lake City and Meriden among other cities."
What are the applications of nab-paclitaxel in medical care?
"nab-paclitaxel is commonly prescribed to help reduce the spread of malignant neoplasms. This medication can also be useful in treating cases such as locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary tract cancers."
What is the capacity of this experiment with regards to participant numbers?
"Astellas Pharma Global Development, Inc. is sponsoring this trial with the goal of enrolling 369 participants that meet the criteria specified in their protocols. Vista Oncology (Olympia, Washington) and Utah Cancer Specialists (Salt Lake City, Utah) are two centres where data collection will take place."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
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