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NUC-3373 for Colorectal Cancer
Study Summary
This trial is testing NUC-3373, a new cancer drug, given by IV infusion. The study will test different combinations of NUC-3373 with other cancer drugs, to find the best dose and schedule for treatment.
- Colorectal Cancer
- Colorectal Tumor
Timeline
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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- You have had a heart attack or significant heart disease in the past year, or you have a high risk of uncontrolled heart rhythm problems.You are currently taking cetuximab or panitumumab.Everyone is included in this criteria.You are at least 18 years old.You have already tried two different treatments for advanced or spread-out colon cancer.You have any medical conditions that make it unsafe for you to take cetuximab or panitumumab, as listed in their prescribing information.You have already received at least three other treatments for your condition before joining this trial.You have already received one or two rounds of treatment.You have a rapidly progressing form of the condition being studied.You have already received one type of treatment for your condition and it did not work, and now you are seeking a second treatment option.You had surgery or wound healing problems within 28 days before starting bevacizumab.You are expected to live for at least 12 more weeks.You have a serious medical condition that is not under control.You have received chemotherapy, radiation therapy, immunotherapy, or another experimental treatment within the last 28 days.You were diagnosed with another type of cancer within the last 5 years.You cannot receive multiple treatments at the same time.You have had an allergic reaction or cannot take any of the drugs being used in the trial.Your liver must be functioning properly, which means that the levels of bilirubin, AST, and ALT in your blood should be within a certain range.You give permission in writing to take part in the study.You have been diagnosed with colorectal cancer that has spread or cannot be surgically removed.You should be able to perform daily activities without any significant limitations.You have a disease that can be measured according to specific guidelines called RECIST v1.1.Your RAS and BRAF genetic status is known.Your blood cell counts are within a healthy range, with a white blood cell count of at least 1.5 billion per liter, platelet count of at least 100 billion per liter (with no signs of bleeding), and a hemoglobin level of at least 9 grams per deciliter.You have a condition that causes blockage in your intestines, ongoing inflammation in your bowel, or long-term diarrhea.You have excessive fluid buildup in your abdominal area (ascites) that causes symptoms and requires frequent drainage.You have severe and ongoing wounds, ulcers or bone fractures.You have high blood pressure that is not being managed or controlled.You have any medical condition that is listed as not safe to use bevacizumab in its prescribing information.You have been told to avoid or reduce your exposure to sunlight.You are currently taking bevacizumab.You have a history of coughing up blood.
- Group 1: NUC-3373 + leucovorin (LV) every other week
- Group 2: NUC-3373 every other week
- Group 3: NUC-3373 + leucovorin (LV) weekly
- Group 4: NUC-3373 + leucovorin (LV); combination chemotherapy ineligible
- Group 5: NUC-3373 + oxaliplatin weekly
- Group 6: NUC-3373 + irinotecan weekly
- Group 7: NUC-3373 + oxaliplatin (NUFOX) expansion
- Group 8: NUC-3373 + irinotecan (NUFIRI) expansion
- Group 9: NUFOX + bevacizumab weekly
- Group 10: NUFOX + bevacizumab every other week
- Group 11: NUFIRI + bevacizumab weekly
- Group 12: NUFIRI + bevacizumab every other week
- Group 13: NUC-3373 + LV + bevacizumab; maintenance patients
- Group 14: NUFOX + cetuximab
- Group 15: NUFIRI + cetuximab
- 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
Are people still able to sign up for this experiment?
"The trial is currently ongoing, as seen from the study's listing on clinicaltrials.gov. This particular research project was first made public on October 16th, 2018 with the most recent update happening January 12th, 2022."
How many individuals are helping to contribute to this research project?
"Yes, the information on clinicaltrials.gov point out that this study is actively recruiting participants. The clinical trial was initially posted on 10/16/2018 and was most recently updated on 1/12/2022. The trial is recruiting for 225 participants across 3 sites."
What are some of the benefits associated with taking NUC-3373?
"NUC-3373 is often used to treat colorectal carcinoma, but it can also help patients with conditions like locally advanced nonsquamous non-small cell lung cancer and sarcoma who have developed an intolerance to irinotecan."
Is NUC-3373 a new or previously explored drug?
"At present, 988 studies are ongoing concerning NUC-3373. 266 of those trials are currently in Phase 3. A large number of these studies originate from Guangzhou, Guangdong; however, 40666 research locations worldwide are conducting investigations into this potential treatment."
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