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Ulixertinib + Hydroxychloroquine for Gastrointestinal Cancer (UTAH Trial)
UTAH Trial Summary
This trial is testing a new cancer drug, ulixertinib, combined with the existing drug hydroxychloroquine. The trial will start with a small group of patients to see if the ulixertinib is safe and what side effects there are. If it is safe, then more patients will be enrolled.
UTAH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowUTAH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 93 Patients • NCT03122431UTAH Trial Design
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Who is running the clinical trial?
Media Library
- I have recovered from previous cancer treatment side effects, or they are mild and stable.I haven't had cancer, except for certain skin, breast, bladder, cervix, or low-grade prostate cancers in the last 2 years.I haven't had a stroke, heart attack, or blood clot in the last 3 months.I had major surgery less than 3 weeks ago or haven't fully recovered from one.I can carry out all my self-care but might not be able to do heavy physical work.I had hepatitis B but it's resolved, or I have hepatitis C but no active virus.I do not have severe heart failure, unstable chest pain, or serious heart rhythm problems.I have cancer that has spread to my brain.My cancer has spread to the lining of my abdomen.My pancreatic cancer worsened after one treatment.I am using or willing to use effective birth control during and for 4 months after the study.My stomach or esophageal cancer has worsened after two treatments.I am post-menopausal or not pregnant if pre-menopausal.My stomach or esophageal cancer has worsened after two treatments.I have or am at risk for blocked blood vessels in my eye due to conditions like uncontrolled glaucoma.I am a woman under 50, have not had periods for 12 months or more, and either have hormone levels indicating menopause or have had surgery to remove my ovaries or uterus.I am a woman who is either not pregnant, post-menopausal, or have had surgery to prevent pregnancy.I do not have serious stomach or bowel problems that could affect drug absorption.My colorectal cancer has worsened after two treatments.I am a woman over 50 and have not had a period for more than a year due to menopause, treatment, or surgery.My gastrointestinal cancer has a specific mutation in the MAPK pathway.I am fully active and can carry on all my pre-disease activities without restriction.My organs are functioning well.My liver function tests are within the required limits, even with liver metastases.My kidneys work well enough, with a creatinine clearance rate of 50 mL/min or more.I had radiotherapy less than 14 days ago, except for treating bone metastasis.I have HIV with a detectable viral load in the last 6 months.I do not have active infections like TB, hepatitis B, or hepatitis C.My pancreatic cancer has worsened despite one treatment.I am on effective HIV treatment with an undetectable viral load.My liver function tests are within acceptable limits despite having liver metastases.My cholangiocarcinoma has worsened after one treatment.My colorectal cancer has worsened after two treatments.I am using or willing to use effective birth control during and for 4 months after the study.I am able to understand and follow the study's requirements.I have stopped taking certain medications as required before starting treatment.I have recovered from previous cancer treatment side effects, or they are mild and stable.I do not have any severe ongoing illnesses.I have a history of seizures.My cholangiocarcinoma has worsened after one treatment.I haven't had cancer treatment or experimental therapy in the last 14 days or within 5 half-lives, whichever is shorter.I am 18 years old or older.My GI cancer has a specific mutation in the MAPK pathway.I am willing and able to sign the consent form for the trial.I am 18 years old or older.My brain metastases are stable, and I haven't needed steroids for 4 weeks.
- Group 1: Treatment: all patients
- 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
How many test subjects are currently enrolled in this experiment?
"Affirmative. The information on clinicaltrials.gov affirms that this research study, which was first advertised on March 17th 2020, is currently recruiting. Only 12 individuals need to be enrolled from 1 healthcare facility."
What medical issues does Ulixertinib usually address?
"Ulixertinib is commonly prescribed for malaria, and has been used to manage a range of ailments including q fever, rheumatoid arthritis, and sjögren's syndrome."
What security measures have been implemented to ensure the judicious use of Ulixertinib?
"Ulixertinib has limited clinical evidence supporting its safety, so it was given a rating of 1 on our scale."
Are there any open opportunities for participants in this research endeavor?
"Affirmative. Information on clinicaltrials.gov reports that this research endeavor, which was initially posted in March of 2020, is actively recruiting volunteers. 12 individuals need to be recruited from a singular medical location."
Are there any preceding investigations into the use of Ulixertinib?
"As of now, there are 70 separate studies related to Ulixertinib treatments ongoing. 7 of these trials have advanced to the third phase and many originate from Hangzhou in Zhejiang province; however, research is also being conducted at 2550 sites globally."
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