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Autophagy Inhibitor

Ulixertinib + Hydroxychloroquine for Gastrointestinal Cancer (UTAH Trial)

Phase 1
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
ECOG Performance Status ≤ 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the day of the first dose, cycle one day one, to cycle one day 28 (cycle=28 days)
Awards & highlights

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.

Who is the study for?
Adults with advanced MAPK-mutated gastrointestinal adenocarcinomas who have already undergone certain treatments without success. They must have good organ function, no major surgery within the last 3 weeks, and no other recent malignancies or serious health conditions. Participants need to be able to provide informed consent and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing a combination of Ulixertinib (BVD-523) with a fixed dose of Hydroxychloroquine in patients with specific mutations in their tumors. It's an open-label study where doses of Ulixertinib will increase to find the safest and most effective level when combined with Hydroxychloroquine.See study design
What are the potential side effects?
Potential side effects may include vision problems like retinal vein occlusion, liver issues reflected by changes in blood tests, digestive disturbances such as nausea or diarrhea, increased risk of infections due to lowered white blood cell counts, fatigue, and possible allergic reactions.

UTAH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from previous cancer treatment side effects, or they are mild and stable.
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I can carry out all my self-care but might not be able to do heavy physical work.
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My pancreatic cancer worsened after one treatment.
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I am using or willing to use effective birth control during and for 4 months after the study.
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My stomach or esophageal cancer has worsened after two treatments.
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I am a woman who is either not pregnant, post-menopausal, or have had surgery to prevent pregnancy.
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My stomach or esophageal cancer has worsened after two treatments.
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My colorectal cancer has worsened after two treatments.
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My gastrointestinal cancer has a specific mutation in the MAPK pathway.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My liver function tests are within the required limits, even with liver metastases.
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My kidneys work well enough, with a creatinine clearance rate of 50 mL/min or more.
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My pancreatic cancer has worsened despite one treatment.
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My liver function tests are within acceptable limits despite having liver metastases.
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My cholangiocarcinoma has worsened after one treatment.
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My colorectal cancer has worsened after two treatments.
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My cholangiocarcinoma has worsened after one treatment.
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I am 18 years old or older.
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My GI cancer has a specific mutation in the MAPK pathway.
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I am willing and able to sign the consent form for the trial.

UTAH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the day of the first dose, cycle one day one, to cycle one day 28 (cycle=28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and the day of the first dose, cycle one day one, to cycle one day 28 (cycle=28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 dose of ulixertinib in combination with a fixed dose of hydroxychloroquine in subjects with advanced, RAS, non-V600 BRAF, ERK or MEK mutated gastrointestinal malignancies
Secondary outcome measures
Efficacy of ulixertinib and hydroxychloroquine in the study population: Objective response rate (PR and CR)
Safety and tolerability of ulixertinib and hydroxychloroquine in the study population: adverse events (AEs) and serious adverse events (SAEs)

Side effects data

From 2021 Phase 4 trial • 93 Patients • NCT03122431
60%
Only sensory peripheral neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
SLE/Cutaneous Lupus With Thalidomide
Inactive SLE With Standard Dose of HCQ
Inactive SLE With Reduced Dose of HCQ

UTAH Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment2 Interventions
Hydroxychloroquine will be provided as 200 mg tablets and will be self-administered by mouth twice daily. Ulixertinib will be provided as 150 mg capsules and will be self-administered twice daily by mouth at the assigned dose level. Both medications will be administered in 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5630

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,089 Previous Clinical Trials
1,728,367 Total Patients Enrolled
BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
720 Total Patients Enrolled

Media Library

Hydroxychloroquine (Autophagy Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04145297 — Phase 1
Gastrointestinal Tumors Research Study Groups: Treatment: all patients
Gastrointestinal Tumors Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT04145297 — Phase 1
Hydroxychloroquine (Autophagy Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145297 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~4 spots leftby Mar 2025