Your session is about to expire
← Back to Search
Autophagy Inhibitor
Ulixertinib + Hydroxychloroquine for Gastrointestinal Cancer
Phase 2
Recruiting
Research Sponsored by BioMed Valley Discoveries, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, or colorectal adenocarcinoma harboring a MAPK-mutated GI malignancy: KRAS, NRAS, HRAS, BRAF non-V600, MEK 1/2 (MAP2K1/2), or ERK 1/2 (MAPK3/1)
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until safety follow-up visit (up to 30 months)
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with advanced gastrointestinal cancers who have a mutation that activates a protein. The trial will have two stages, and enrollment in the second stage will depend on how well patients respond to the drugs in the first stage.
Who is the study for?
Adults with advanced gastrointestinal cancers harboring MAPK mutations, who have progressed after standard treatments. Eligible participants include those with specific types of esophageal, gastric, pancreatic, or colorectal cancer. They must not be pregnant, agree to use effective contraception and have adequate organ function. Excluded are individuals with recent antineoplastic therapy or surgery, other malignancies within 3 years (except adequately treated), uncontrolled illnesses or infections like hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing the combination of Ulixertinib and Hydroxychloroquine in patients with certain gastrointestinal cancers that carry a MAPK mutation. It's an open-label phase two study where responses from an initial group determine if a second stage proceeds.See study design
What are the potential side effects?
Potential side effects may include vision problems like retinal issues, increased risk of infection due to immune system impact, digestive disturbances given the GI focus of treatment, and general reactions such as fatigue or skin sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of the listed types and has a specific mutation.
Select...
I can carry out all my self-care but might not be able to do heavy physical work.
Select...
My condition worsened despite treatment.
Select...
My cancer can be measured on scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until safety follow-up visit (up to 30 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until safety follow-up visit (up to 30 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate as defined by the proportion of patients achieving a confirmed partial response (PR) and complete response (CR) (defined by response evaluation criteria in solid tumors (RECIST 1.1) as evaluated by the local treating investigator.
The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NCI CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
Secondary outcome measures
Progression-free survival (PFS) as defined as the time from study drug initiation to the time of documented disease progression (as assessed by RECIST 1.1) or death from any cause.
Side effects data
From 2021 Phase 4 trial • 93 Patients • NCT0312243160%
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 2 - basket expansion based on Stage 1Experimental Treatment2 Interventions
Ulixertinib: 450mg BID, orally, days 1-28
Hydroxychloroquine: 600mg BID, orally, days 1-28
Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Group II: Stage 1 - 5 baskets included, based on primary diseaseExperimental Treatment2 Interventions
Ulixertinib: 450mg twice daily (BID), orally, days 1-28
Hydroxychloroquine: 600mg BID, orally, days 1-28
Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
2020
Completed Phase 1
~20
Hydroxychloroquine
2017
Completed Phase 4
~5360
Find a Location
Who is running the clinical trial?
BioMed Valley Discoveries, IncLead Sponsor
16 Previous Clinical Trials
523 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment or experimental therapy in the last 14 days or within five half-lives, whichever is shorter.My cancer is one of the listed types and has a specific mutation.I agree to use effective birth control during and for 3 months after the study.I do not have any severe illnesses that would stop me from joining the study.My blood, liver, and kidney functions are all within normal ranges.I can carry out all my self-care but might not be able to do heavy physical work.I am able to understand and follow the study's requirements.My condition worsened despite treatment.I am not taking any medications that are not allowed in the study.I had radiotherapy less than 2 weeks before starting the study treatment.I have or had eye conditions like CSR or RVO, or I'm at risk for RVO.I do not have an active infection like TB, hepatitis B, or C.I am 18 years old or older.My cancer can be measured on scans.I had major surgery less than 3 weeks ago or haven't fully recovered from one.I haven't had any other cancer besides this one in the last 3 years, or if I did, it's fully treated with no current signs or symptoms.I am willing to undergo biopsies as required by the study schedule.I have recovered from side effects of previous cancer treatments.I've had surgery on my stomach or upper intestine that affects how I absorb medication.I have untreated brain metastases or cranial epidural disease.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 - 5 baskets included, based on primary disease
- Group 2: Stage 2 - basket expansion based on Stage 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this trial still open?
"This medical study is actively enrolling patients, and the clinicaltrials.gov page confirms this information was posted on May 26th 2022 and recently edited November 28th of that same year."
Answered by AI
What danger could patients potentially encounter when taking Ulixertinib?
"Our team at Power rated Ulixertinib's safety as a 2 due to the existing evidence of its security, but lack thereof in terms of efficacy. This is because it is currently undergoing Phase 2 medical trials."
Answered by AI
In how many sites is this clinical experiment being conducted?
"Mount Sinai in New york, Massey Cancer Center at Virginia Commonwealth University of Richmond, and the University of Arizona's Cancer Centre in Tucson are 3 primary locations seeking participants. Additionally, 6 other medical centres throughout North America have been assigned to this study."
Answered by AI
Approximately what number of participants is being recruited for this experiment?
"Affirmative. The information provided on clinicaltrials.gov confirms that this medical experiment has been made available to the public since May 26th 2022 and is presently searching for 215 participants across 6 research sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger